LITHUANIAN UNIVERSITY OF HEALTH SCIENCES MEDICAL ACADEMY
FACULTY OF MEDICINE DEPARTMENT OF PEDIATRICS
NON-PHARMACOLOGICAL ACUTE PROCEDURAL PAIN
TREATMENT IN CHILDREN:
A SYSTEMATIC REVIEW
Beatriz García Contreras
Final Master’s Thesis
Supervisor: MD, PhD. Lina Jankauskaite Consultant: MD. A. Dagys
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TABLE OF CONTENTS
1. SUMMARY………...3
2. ACKNOWLEDGEMENTS………...4
3. CONFLICTS OF INTEREST………...5
4. ETHICS COMMITTEE APPROVAL………...5
5. ABBREVIATIONS………...6
6. TERMS………...7
7. INTRODUCTION………...8
8. AIMS AND OBJECTIVES ………...9
9. LITERATURE REVIEW………...10
9.1 Paediatric pain………...10
9.2 Acute pain assessment in children………...11
9.2.1 Pain assessment strategies………...11
9.2.2 Paediatric pain assessment scales………...13
9.3 Non-pharmacologic paediatric pain management………...16
10. RESEARCH METHODOLOGY AND METHODS………...18
10.1 Protocol and registration………...18
10.2 Research question………...18 10.3 Search strategy………...18 10.4 Information sources………...18 10.5 Eligibility criteria………...19 10.6 Study search………...19 10.7 Study selection………...20
10.8 Data extraction and synthesis………...20
10.9 Assessment of risk of bias………...20
10.10 Assessment of quality of evidence………...22
11. RESULTS………...24
11.1 Study selection………....24
11.2 Study characteristics………....25
11.3 Results of individual studies………....27
11.4 Risk of bias assessment………...28
11.5 Quality of evidence assessment………..30
12. DISCUSSION………...32
13. CONCLUSIONS………...33
14. PRACTICAL RECOMMENDATIONS………...34
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1. SUMMARY
Aim: To perform a systematic review assessing different non-pharmacological treatment methods. To address their efficacy and to provide practical recommendations during acute procedures in children.
Objectives: To report about the pain experienced by children during acute procedures, to name the different non-pharmacological treatment methods and to obtain conclusions of how useful these methods are.
Methodology: A systematic review was performed following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) according to the strictly established criteria in order to minimize bias. The research is carried out in different databases such as Medline (PubMed), Google scholar and Embase including articles in the 10 past years embracing paediatric population from 0 to 18 years old.
Study participants: The population selected for this research are children from 0 to 18 years old (y.o.).
Results: The four studies analysed have demonstrated the usefulness of distraction methods during acute procedures in order to reduce pain. These results are based on Randomized Control Trials (RCTs) which divide samples into an experimental group, which is provided with the distraction method and a control group, which has no non-pharmacological treatment showing lower levels of pain while using distraction techniques.
Conclusions: Distraction methods as non-pharmacological treatment during acute painful procedures on childrenare effective on reducing pain perception.
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2. ACKNOWLEDGEMENTS
This research is a part of my integrated studies of Medicine in the Lithuanian University of Health Sciences (Medical Integrated Master’s Study Programme) as Final Master Thesis (FMT), carried out and to be presented during my last 6thyear.
I would like to personally thank my tutor Lina Jankauskaite because from the first moment she accepted with enthusiasm to be part of this, for her full collaboration, involvement, help and willingness to undertake this research and total availability even being for some time many kilometres away.
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3. CONFLICTS OF INTEREST
There are no conflicts of interest.
4. ETHICS COMMITTEE APPROVAL
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5. ABBREVIATIONS
PRISMA -Preferred Reporting Items for Systematic Reviews and Meta-Analyses Y.O. - Years Old
FMT - Final Master Thesis
IASP - International Association for the Study of Pain
WHO - World Health Organization EM - Emergency Medicine
PER - Paediatric Emergency Room CNS - Central Nervous System HR - Heart Rate
RR - Respiratory Rate BP - Blood Pressure
NRS - Numeric Rating Scales VAS - Visual Analog Scale CAS - Colour Analog Scale FPS-R - Faces Pain Scale-Revised
QUADAS - Quality Assessment of Diagnostic Accuracy Studies
GRADE - Grading of Recommendations Assessment, Development and Evaluation BPM - Beats Per Minute
JIA - Juvenile Idiopathic Arthritis RCT- Random Controlled Trials
Non-RCT - Non-Random Controlled Trials SoF - Summary of Findings
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6. TERMS
Numeric rating scales (NRS) -It is a subjective scale designed to assess pain in which patients use numbers in order to describe their pain. It starts from 0 (no pain at all) to 10 (worst possible pain) (1).
Visual Analog Scales (VAS) -It is a ten centimetres line with two end-points that reflects limits of pain intensity (from No Hurt-Hurt most). The patient is asked to place a vertical mark on the scale to indicate the grade of his/her pain (2).
Categorical scales -Scales that employ words as the main tool to evaluate pain: “mild”, “discomforting”, “distressing”, “horrible” and “excruciating”. They may also contain colours, numbers or other symbols (3).
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7. INTRODUCTION
Pain is one of the most misunderstood, under-diagnosed and under-treated/untreated medical problem, especially in children. It is a dual entity composed of both a physical and an emotional part. Each child perceives pain in a different way, and the meaning of it differs also from one child to another. Due to these barriers, it is a daily challenge to healthcare professionals to correctly asses and treat it (4).
As pain is a personal and subjective experience, it can be described in many different ways. Furthermore, assessment of pain in children is related to the degree of child’s development, personal experience or cultural believes. Children with the same age can have a really diverse perception and tolerance to pain (5).
Increasing evidence has demonstrated that pain during venepuncture or intravenous cannulation is an important source of paediatric pain and has a lasting impact. Ascending sensory neural pain pathways are functioning in preterm and term infants, yet descending inhibitory pathways seem to mature postnatally. Consequently, infants may experience pain from the same stimulus more intensely than older children (6).
It exists a really marked need to improve and create guidelines for the clinical practice to cope better with painful procedures in children.
Through this study I want to expose the non-pharmacological strategies to treat pain used in different Paediatric emergency departments. For this propose, this systematic review was conducted collecting data from such databases as Medline, Embase and Google Scholar. The data of last ten years was selected as a study period. The main aim of this systematic review was to clarify the safety and effectiveness of non-pharmacological acute pain treatment methods evaluating evidence and bias of the already published information in order to remove duplicated information and the presentation of some reliable basis for decision making.
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8. AIMS AND OBJECTIVES
The aim of this systematic review is to evaluate and list the different alternative non-pharmacological treatment methods in order to reduce the pain experienced during acute procedures in childhood by looking for and analysing different articles included in the past 10 years located in Medline (PubMed), Google scholar and Embase databases. Moreover, in this systematic review I seek if non-pharmacological methods are efficient in pain reduction. And finally, to provide practical recommendations for non-pharmacological treatment application during acute procedural pain in children.
The objectives to achieve during the research were the following:
1. To search articles on the different databases and list the alternative non-pharmacological methods existing of how to treat acute procedural pain in children from 0-18 years old.
2. To extract results and conclusion above how effective are these non-pharmacological treatment methods.
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9. LITERATURE REVIEW
9.1 Paediatric pain
The International Association for the Study of Pain (IASP) defines pain as “An unpleasant sensory and emotional experience associated with actual or potential tissue damage” (7). Pain is a stressful experience which constitutes a global health problem. It is recognized by the World Health Organization (WHO) that every person has the right to be furnished by pain relief and treatment. Countries must provide pain treatment as part of their core obligations under the right to health; failure of this may result in the violation of the obligation to protect against cruel, inhuman and degrading treatment (8).
For many years, pain management in paediatric field wasn’t a priority since the treatment was focused only on aetiology because there was a series of preconceived ideas. Some of them stated that children perceived pain with less intensity due to biological immaturity of their central nervous system (CNS), or that child is hardly able to remember painful experiences. Other theories asserted that children have higher threshold for pain than adults and children are more sensitive to the adverse effects of pain-relievers. These erroneous theories led, in practice, to not taking the correct assessment and treatment of the pain in the same way that was done in adults. Nowadays the concept is changing, and more and more pain-research are showing that none of these theories were true (9).
Premature babies, neonates and older children feel pain in the same way as adults. Anatomic and physiologic nociceptive pathways are present above the 26th week of gestation. Around the third trimester of gestation, several peripheral and CNS structures involved in nociception develop and, although myelination is not yet completed by this time, it only results in lesser speed of nociceptive transmission when compared to adults in who is fully myelinated. Although, neonates or infants are not able to describe their pain feeling in language but most of their anatomical and neurochemical structures at this period can produce stressful and unpleasant effects as strong and persistent as they do in other periods of life (10).
Paediatric pain, its assessment and management constitute a daily challenge both for the child himself, for his parents and for health care professionals. This occurs especially in emergency medicine (EM), where patients in a paediatric emergency room (PER) undergo acute painful procedures which are a major source of distress, anxiety and pain. Such procedures -venepuncture or needle blood sampling- are one of the most common sources of acute painful stimulus in a child as it
11 has been demonstrated that around 80% of patients go through them in an acute context (ex: during EM). Furthermore, painful procedures are usually unexpected; patient does not have time to prepare for them so it boosts hospital-related stress and anxiety leading to unpleasant experiences and bad memories associated with medical settings. This bad experience can even have a negative effect on the procedure outcomes. It may further impact future visits to health centres and intensify patient’s fears and anxiety (11). It derives in negative psychological and emotional consequences resulting in long-term impact on behaviour and perception of pain as well as pain understanding: it can have a negative repercussion on eating and sleeping processes, give arise to post-traumatic stress disorder, interfere/diminish social skills or increase fears (11) (12).
9.2Acute pain assessment in children
Pain is a complex entity which involves physiological, psychological and behavioural aspects. Owing to this reason, it is difficult to assess it correctly and often leads to underestimation and under-treatment. This precision deficiency and erroneous perceptions occur because of the difficulty to recognize specific pain signs and because of the different individual reactions and/or pain perception of a child (13).
There are different scales designed to assess and evaluate pain intensity, especially in children who lack of communication skills. No particular scale is better than other; they depend on a different situation, individual child and experience of medical stuff. Despite all the continuous advances being made in this field of paediatrics, there is still a marked need to create more accurate methods of pain diagnosis (13) (14).
9.2.1 Pain assessment strategies
There are three approaches to evaluate pain in children (15):
Self-report indicators – what the child says Behavioural indicators – how the child behaves Physiological indicators – how the child’s body reacts
12 understand and communicate, who are not suffering over-distress and who do not have a cognitive dysfunction. Self-report is a golden standard of pain assessment (15).
On the other hand, behavioural indicators are used for those who are less than three years old still with immaturity of communication abilities, who are sedated or have cognitive dysfunction. As an exception, it can be used in children who are capable to use self-report indicators but at the time of diagnosis are over-stressed. These behavioural indicators do not show an exact level of pain of the child. Thus, it is important to know how a child normally reacts to pain to correctly interpret it. The signs and reactions included as behavioural indicators are shown in Table 1 (15).
Finally, physiological indicators are the following ones: heart rate (HR), respiratory rate (RR) and pattern, blood pressure (BP) and oxygen saturation (Table 2). They cannot be used alone as they may be affected by pathological processes such as fever or anxiety (15).
Table 1. Behavioural indicators of pain in children (15)
Behavioural indicators of pain in children Irritability
Unusual posture Reluctance to move Disturbed sleep pattern Unusual quietness Restlessness Sobbing Lethargy Screaming Aggressiveness Increased clinging Loss of appetite Whimpering
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Table 2. Physiological indicators of pain in children (15)
Indicator Evidence
Heart rate (HR) Increases immediately after a pain stimulus and decreases as pain diminishes except in infants, in whom an initial decrease is followed by a rise
Respiratory rate (RR) and pattern
Conflicting evidence about whether respiratory rate increases or decreases, but significant shift from baseline. Breathing may become rapid and/or shallow
Blood pressure (BP) Increases when a child is in acute pain Oxygen saturation Decreases when a child is in acute pain
9.2.2 Paediatric pain assessment scales
Paediatric pain assessment scales are tools used to help to evaluate pain level. They improve communication between doctor and patient and transmit in an easier way how severe is pain feeling in children (14).
They are classified into categories (14):
- Numeric rating scales (NRS): they use numbers as tool to rate pain. It starts from 0 (no pain at all) to 10 (worst possible pain). Belonging to this group: Numerical Rating Pain Scale (See
Fig. 1) and Cries Scale (See Fig. 2)
- Visual Analog Scale (VAS): patient needs to point a specific position along a continuous line of with two end-points that reflects limits of pain intensity (from No Hurt-Hurt most). Examples of them are: Wong-Baker Faces Pain Scale (See Fig.3) and Colour Analogue Scale (CAS) (See Fig. 4).
- Categorical scales: they use words as the tool to rate pain: “mild”, “discomforting”, “distressing”, “horrible”, and “excruciating”. They may also add colours, numbers or other symbols.
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Table 3. Paediatric pain assessment scales (14)
Scale Components Age Interpretation
Numerical Rating Pain Scale (See Fig. 1)
Numbers Older than 9 years It goes from 0, which means no pain till 10, which express the most painful situation
Cries Scale (See Fig. 2) Parameters
measured: crying, oxygenation, vital signs, facial expression, and sleeplessness It is used from newly-born to six months old (neonatal care setting)
It rates using two points to each parameter, with a rating of 0 for signs of no pain and a rating of 2 for signs of maximal pain. It is based in observations and objective measurements Wong-Baker Faces Pain
Scale (See Fig. 3)
It is composed of six faces (pictures), each one assigned to a number
Older than 3 years The first one means extremely happy (0) and the last one extremely painful (10)
Colour Analogue Scale (CAS) (See Fig. 4)
Colours Older than 4 years -Red: severe pain -Yellow: moderate pain -Green: comfort
The colours are usually positioned in a linear format with corresponding numbers or words that describe your pain
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Fig.2. Cries Scale (14)
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Fig.4. Colour Analogue Scale (16)
9.3 Non-pharmacologic paediatric pain management
Non-pharmacological pain treatment refers to any kind of treatment in which is not involved a drug. This method is based on altering thoughts and moving attention and/or concentration in order to reduce pain feeling. There are several types of non-pharmacological treatment: education and psychological preparing, hypnosis, distraction, relaxation techniques, music, exercises, aqua-therapy, etc (17).
It has been demonstrated that non-pharmacological management of pain based on distraction strategies can turn the negative effect into a positive impact and thus reducing the aversive aspects of acute painful procedures. The aim of the distraction is to displace patient’s attention from the medical procedure. This positive transformation can switch painful experience into more pleasant sensations with regard to fear and affective responses to painful experiences. Distraction method is thought to comprise imagination, engagement and motivation of the child in order to learn to develop his own distraction system using different types of distractors (12) (18).
Venepuncture is one of the most common invasive techniques carried out during acute procedures in which children suffer from pain, refuse to cooperate and cry. It has been demonstrated that audiovisual distraction is effective in reducing pain and makes child to collaborate. In addition, it is a low-cost non-pharmacological treatment. Therefore, these two positive consequences of
17 audiovisual distraction produce a better relation health-care setting and patient, making future visits to hospital more bearable (19).
Distractors can be of various degrees of complexity. Simple distraction methods are music or story via headphones, party blower, non-procedural talk by parent or professional, cartoon, toy, kaleidoscope, story and poster. Packages include several techniques at the same time as imagery and reinforcement, breathing and rehearsal, relaxing images, non-procedural talk and concentrating. They can be used in children from three years old. All of them have also demonstrated their effectivity during medical procedures by reducing patient’s pain and distress (20).
Other non-pharmacological strategies have shown also its efficacy in diminishing pain during acute medical procedures such as hypnosis, breathing, inflating a balloon and combining multiple psychological approaches. They can be used in children from two to nineteen years old who are undertaking needle procedures in the hospital, in a clinic or even in the school (21).
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10. RESEARCH METHODOLOGY AND METHODS
10.1 Protocol and registration
This scientific research is a systematic review accomplished following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), an evidence-based minimum set of items for reporting in systematic reviews and meta-analyses (22)(23).
Articles included in the review were assessed by different tools: QUADAS instrument (24) was used for the risk of bias, while GRADE system (25) was used for the evidence evaluation.
The final writing process for the Final Master Thesis (FMT) was following the structural requirements proposed by the Lithuanian University of Health Sciences (LSMU) (26).
10.2 Research question
The research question was formed using PICO (population, intervention, control, outcome) format (27).
The aim of this review was to report about different non-pharmacological treatment methods in order to reduce the pain experienced during acute procedures in children.
10.3 Search strategy
The systematic review involved a comprehensive online search through different databases applying specific criteria and keywords listed in the section “Eligibility criteria” in order to do a selective and accurate investigation.
10.4 Information sources
The search of articles was made online using electronic databases as following: Medline (PubMed), Google scholar and Embase. Additionally, reference list of each article was crosschecked looking for new articles.
The investigation through the mentioned databases was done by filtering the articles according to the eligibility criteria listed below.
19 10.5 Eligibility criteria
Articles meeting these criteria were eligible for our systematic review: only English-language articles, clinical trials, clinical cases, retrospective/prospective analysis, articles not older than 10 years, free articles, studies conducted in children (comprising ages from 0 to 18 years old), human studies.
Non-English language, meta-analysis, systematic reviews, literature reviews, editorial letters, short comments, opinions, articles older than 10 years, adult studies, studies analysing chronic pain or other conditions/diseases different from pain were not included into this review (Table 4).
Table 4. Inclusion/Exclusion criteria
Inclusion criteria Exclusion criteria
Only English-language articles Clinical trials, clinical cases, retrospective/prospective analysis
Articles not older than 10 years
Studies conducted in children (comprising ages from 0 to 18 years old)
Acute pain
Free of charge articles Human studies
Non-English language
Meta-analysis, systematic reviews, literature reviews, editorial letters, short comments, opinions
Articles older than 10 years Adult studies
Chronic pain No-free articles
Other conditions/diseases different from pain Animal studies
10.6 Study search
The investigation through the mentioned databases was done filtering the articles according to the eligibility criteria listed in the section “Eligibility criteria”.
Furthermore, different keywords were employed as follows: “child” OR “paediatric” OR “pediatric” AND “acute pain” OR “painful” AND “paediatric/pediatric procedures” OR “venepuncture/venipuncture” OR “needle” AND “non-medical treatment” OR “non-pharmacological treatment” OR “paediatric/pediatric management”.
20 10.7 Study selection
Article selection process was made according to the PRISMA flow diagram (22).
The search was initiated by identification of the articles related to the topic via three levels of selection: title, abstract and full-text. Keywords mentioned above were used in order to help the research process. In the first-level screening duplicates were removed.
Subsequently, articles screened were assessed for eligibility according to the previously established inclusion and exclusion criteria. The majority of articles were excluded due to the non-compliance of the criteria. Upon the most common reasons of exclusion were as following: age (focusing in adults), articles centered on pharmacological treatment, meta-analysis, systematic reviews, editorial letters, conference abstracts or experimental studies.
Finally, the adequacy of full-text articles was evaluated. The PRISMA flow-chart was developed demonstrating article selection process (22).
10.8 Data extraction and synthesis
From the final pool of articles selected, all of them were carefully read and analysed one by one. General information was collected: authors, year of publication, country, sample size, study population age range, study design, type of non-pharmacological treatment and results summary. All this information was systematized and arranged into Table 7.
10.9 Assessment of risk of bias
Every research needs to be designed, conducted and reported in a transparent way, honestly and without any deviation from the truth. Research which is not compliant with those basic principles is misleading. Such studies create distorted impressions and false conclusions and thus can cause wrong medical decisions, harm to the patient as well as substantial financial losses (28).
Bias is any trend or deviation from the truth in data collection, data analysis, interpretation and publication which can cause false conclusions. Bias can occur either intentionally or unintentionally. Every scientist should thus be aware of all potential sources of bias and undertake all possible actions to reduce or minimize the deviation from the truth (28).
In this study we used QUADAS instrument (Cochrane Collaboration) to evaluate risk of bias of the selected studies (24).
21 QUADAS tool analyses 11 items. The benefit of reassessing such criteria as part of the quality evaluation includes documenting the evidence that the criteria was met, and clearly reporting all aspects of study quality in the review report (24).
QUADAS is a generic tool developed specifically for use in diagnostic test accuracy reviews. The recommended 11 QUADAS items to assess are exposed in this table: (29)
Table 5. Recommended quality items derived from QUADAS tool (Whiting 2003) (29)
Items Recommended quality items derived from QUADAS tool
Item 1. Was the spectrum of patients representative of the patients who will receive the test in practice? (representative spectrum)
Item 2. Is the reference standard likely to classify the target condition correctly? (acceptable reference standard)
Item 3. Is the time period between reference standard and index test short enough to be reasonably sure that the target condition did not change between the two tests? (acceptable delay between tests)
Item 4. Did the whole sample or a random selection of the sample, receive verification using the intended reference standard? (partial verification avoided)
Item 5. Did patients receive the same reference standard irrespective of the index test result? (differential verification avoided)
Item 6. Was the reference standard independent of the index test (i.e. the index test did not form part of the reference standard)? (incorporation avoided)
Item 7. Were the reference standard results interpreted without knowledge of the results of the index test? (index test results blinded)
Item 8. Were the index test results interpreted without knowledge of the results of the reference standard? (reference standard results blinded)
Item 9. Were the same clinical data available when test results were interpreted as would be available when the test is used in practice? (relevant clinical information)
Item 10. Were uninterpretable/intermediate test results reported? (uninterpretable results reported)
Item 11. Were withdrawals from the study explained? (withdrawals explained)
All items included in Table 5 have been phrased in such a way that they each relate to a single aspect of quality and can be judged as ‘yes’, ‘no’, or ‘unclear’. A judgement of ‘yes’ always refers to
22 the optimal methodological characteristic; the judgement of ‘no’ always refers to the less than optimal characteristic. The more optimal methodological characteristics (yes), the less potential bias.
10.10 Assessment of quality of evidence
The GRADE system rates the quality (or certainty) of the evidence. GRADE serves to assess the quality of the evidence for each outcome in a review, from a rating of: HIGH, MODERATE, LOW and VERY LOW (25).
It starts with a baseline rating of HIGH for Random Controlled Trials (RCTs), and LOW for non- Random Controlled Trials (non-RCTs). This baseline rating can then be adjusted (downgraded or, less commonly, upgraded) after considering 8 assessment criteria and making a judgement about quality based on these (25).
Reasons to downgrade the evidence quality (5): 1. Risk of Bias
2. Inconsistency 3. Indirectness 4. Imprecision 5. Publication Bias
If a no serious concern exists do not downgrade quality from the baseline quality
If a serious concern exists, downgrade the evidence one level, e.g. from high to moderate (-1) If a very serious concern exists, downgrade the evidence two levels, e.g. from high to low (-2)
Reasons to upgrade the evidence quality (3): 6. Large Magnitude of Effect
7. Dose Response
8. Effect of all plausible confounding factors would be to reduce the effect (where an effect is observed) or suggest a spurious effect (when no effect is observed)
For these three criteria, evidence can be upgraded once (+1) or twice (+2).
It is rare to upgrade the quality of the evidence (e.g. upgrading from a starting rating of low quality for very well-designed and conducted observational studies).
23 It is very rare to upgrade evidence from randomized controlled trials that has been downgraded (i.e. upgrading (based on one of the reasons listed below) a trial that has been downgraded based on risk of bias, imprecision or other criteria).
For observational studies, only evidence from studies with no important threats to validity should be upgraded (25).
Based on my assessments, I will decide the final level of evidence of each outcome.
Summary of findings (SoF) table presents the results (together with the GRADE rating) for the most important outcomes in the review (25).
Table 6. GRADE ratings and their interpretation (25)
Symbo l
Quality Interpretation
++++ High We are very confident that the true effect lies close to that of the estimate of the effect.
+++ Moderate We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
++ Low Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate on the effect.
+ Very low We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate effect.
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11. RESULTS
11.1 Study selection
Article selection has been performed according to PRISMA flow diagram (Fig. 6)(22). In the identification phase, a total of 13 articles were detected in Medline (PubMed). No duplicates were found in Google Scholar and Embase databases with the keywords previously established. On the screening phase, one of the articles was excluded due to its title (“Managing chronic pain in children
and adolescents: a clinical review”). In the eligibility phase, full-text articles were analysed according
to the inclusion/exclusion criteria previously cited. Eight articles were excluded due to the non-compliance of these as following: age (instead of being children they also included adults), treatment (apart from non-pharmacological treatment was also included pharmacological) and type of the study (some of them were meta-analysis or systematic reviews). Finally, four articles reunited all criteria.
25 11.2 Study characteristics
The main characteristics of the included studies are systematized in the following Table 7 in the following order: authors, year of publication, country, sample size, age of patients, type of study, non-pharmacological method registered and a brief summary of the results.
Table 7: Study characteristics
Authors Year of publica tion Country Sample size Age Type of study Non-pharmacological method Results summary Oliveira et al.(12) 2017 Brazil 40 6-11 y.o. A controlled randomized clinical trial (cross-over study) Audiovisual distraction: Animated short-films Use of audiovisual distraction decreases the intensity of pain perception during procedures Canbulat et al.(30) 2014 Turkey 188 7-11 y.o. A prospective, randomized controlled trial Distraction methods: Distraction cards and kaleidoscope
Distraction cards and kaleidoscope are both effective methods for pain and anxiety relief of children
during phlebotomy (specially distraction cards)
26 Weintrau b et al.(31) 2014 Israel 32 5-18 y.o. A prospective, non-randomized clinical trial Distraction method: Medical clowns in combination with Nitrous Oxide Sedation Active participation of a medical clown during
IACI with nitrous oxide for juvenile idiopathic arthritis further
decreases pain and stress and results in a positive patient experience Ramírez et al.(32) 2017 Mexico 40 5-9 y.o. A controlled-randomized clinical trial Distraction method: Hypnosis in combination with conventional techniques of behaviour management Hypnosis combined with conventional behaviour management techniques
decreases heart rate during dental anaesthetic
infiltration showing that there may be an improvement in anxiety/pain control through
hypnotic therapy
All studies were carried out in the past 10 years and were available in English language. Three of them had same age, between 5-11 y.o. except one that included children until 18 y.o. Three of them also shared similar amount of sample population: around 40 patients, with the exception of one that comprises more than 100 patients. The four studies were focused on the distraction method as the preferred strategy of non-pharmacological pain treatment. Parents were present with their child during all the procedure in all four studies. All of them used different pain scales (VAS, Faces Pain Scale-Revised, Wong Baker FACES Pain Rating Scale, FLACC scale) to measure pain level. The four studies used distraction as non-pharmacological technique during acute paediatric needle procedures: two studies analysed distraction techniques during venepuncture, one studied response during
27 corticosteroid injection and in the other dental anaesthetic infiltration. Furthermore, the four articles shared the same goal: to investigate the efficacy of a chosen distraction method for acute pain relief.
On the other hand, these four studies were performed in different continents, thus, in a totally different socio-cultural environment. Also, there are differences in the sample sex distribution: in two of them girls predominate over boys and in the resting two studies is almost equal the percentage of both genders. The main limitation of all these studies is the small sample size.
11.3 Results of individual studies
Oliveira et al. (12) Sample consisted of 40 inpatients who were randomized into two groups to undergo painful puncture procedure (venepuncture/arterial puncture). Group 1 (n=22) and Group 2 (n=18) received all the same non-pharmacological intervention which was audiovisual distraction (animated short films) and served also as their own controls. The sequence of the intervention was opposite: while Group 1 had the intervention during the first puncture procedure, Group 2 was control. Then, sequence order was changed. There was a significant difference in pain scales between periods with/without distraction intervention in both groups, being lower during distraction compared with no intervention. The sequence of exposure to the distraction influenced also the efficacy of the intervention: Group 1 (who received the intervention during the first painful procedure) benefited more from the intervention in the second procedure than Group 2. Furthermore, in the analysis of the carryover effects in the second procedure showed that 29% of pain relief was attributable to the distraction technique.
Canbulat et al. (30). Sample consisted of 188 children who required blood tests. They were randomized into three groups: two using non-pharmacological intervention; Kaleidoscope Group (n=62) and Distraction Cards Group (n=63) while the third did not use any non-pharmacological intervention as it was Control Group (n=63). Distraction Cards Group obtained the lowest pain levels, followed by Kaleidoscope Group. Control group got the highest pain levels.
Weintraub et al. (31). Sample was composed of 32 children who undergone 46 painful procedures: intra-articular corticosteroid injection for Juvenile Idiopathic Arthritis (JIA) was administered during active participation of a medical clown in combination with Nitrous Oxide sedation. From the total sample, only 5 patients experienced an increase of pain level while the rest decreased pain and had a positive experience.
Ramírez et al. (32). Sample size contained 40 children. They were randomized into Experimental Group (n=20) and Control group (n=20). Heart rate, skin conductance and pain scale
28 were assessed at the beginning and at the moment of the painful procedure. All patients underwent dental anaesthetic infiltration while using conventional behaviour management techniques. In addition, the Experimental Group had also hypnosis intervention. Heart rate was increased + 5 beats per minute (bpm) in the Control Group in regard to baseline while there were no differences in pain level noticed in skin conductance and pain scale.
11.4 Risk of bias assessment
To study risk of bias among studies we used QUADAS tool which is based in the analysis of 11 items shown in Table 5 (24).
Table 8. Methodological quality summary (from Leeflang 2008)
Oliveira et al. (12) Canbulat et al. (30) Weintraub et al. (31) Ramírez et al. (32) QUADAS tool 1.Representative spectrum? + + + + 2.Acceptable reference standard? + + + + 3.Acceptable delay between tests? + + - + 4.Partial verification avoided? ? ? ? ? 5.Differential verification avoided? + + + + 6.Incorporation avoided? - - - - 7.Reference standard results blinded? - ? - +
8.Index test results blinded? - ? - + 9.Relevant clinical information? + + + + 10.Uninterpretable results reported? + + + + 11.Withdrawals explained? + + + +
29 Oliveira et al. (12) has low risk of bias as majority of items (7/11) were qualified as (+). Data that support this outcome are the following: the spectrum of patients satisfies the pre-established requirements (sample comprised 40 inpatients from 6–11 y.o.). The reference standard is chosen correctly to assess pain (before the painful procedure, stress and pain-catastrophizing assessment were evaluated using Pain-catastrophizing scale for children and Child Stress Scale. After the painful procedure, pain assessment was performed using Visual Analog Scale (VAS) and Faces Pain Scale-Revised (FPS-R). Time between the procedure and the reference standard is short enough; painful procedures occurred at time intervals of at least 1 day and a maximum of 7 days. This time interval between puncture procedures was established to guarantee subject participation in the study, reduce the dropout rate and control possible changes in the clinical status of the paediatric inpatients. All patients were assessed using the same tests as well as all data were collected in the hospital setting thus results can be generalized regardless patient’s diagnosis. There are no uninterpretable results and it is clear what happened with all patients (number of patients matches with the analysis).
Canbulat et al. (30)was also evaluated as low risk of bias. The total item qualified as (+) are 7/11: the spectrum of patients satisfies the pre-established requirements (sample consisted of 188 children who were between 7-11 y.o.). The reference standard is chosen correctly to assess pain (pain levels were assessed by the parents, the observer as well as self-report using the Wong Baker FACES Pain Rating Scale. The anxiety levels of children were assessed by parents and observer reports using Children Fear Scale). Time between the procedure and the reference standard is short enough (the different distraction methods were applied just at the beginning of the phlebotomy and continued until the end of it. After the procedure, pain was assessed using the Wong Baker FACES Pain Rating Scale as well as anxiety, using Children Fear Scale). All patients were assessed using same tests. Clinical data about background demographic information, medical history, recent analgesics, and body mass index were collected via self-report forms. There are no uninterpretable results and it is clear what happened with all patients (no withdrawals).
Weintraub et al. (31) has moderate risk of bias. The items qualified as (+) were (6/11): the spectrum of patients satisfies the pre-established requirements (a total of 23 girls and 9 boys with an age range 5–18 y.o.). Acceptable reference standard (in order to rate pain were used VAS and HR). All patients were assessed through same tools. Clinical data were available when results were interpreted (age of the patients, disease (JIA) and propose of intervention: corticosteroid injection) and there are no uninterpretable results and no withdrawals or exclusions.
On the other hand, there are 4/11 items qualified as (-): it is not acceptable delay between tests (number of injections was different from some patients to others and VAS was recorded once all injections were done, so time from the injection till VAS was not the same for all patients). Same tests
30 were used as the reference and index tests at the same time and the study was not blinded. Finally, 1/11 item was qualified as unclear (?): information about partial verification is unclear.
Ramírez et al. (32) has low risk of bias. It has 9/11 items qualified as (+): the spectrum of patients satisfies the pre-established requirements (a total of 40 healthy children; 16 boys and 24 girls aged 5 to 9 y.o.). It has an acceptable reference standard (in order to rate pain were used FLACC scale, HR and skin conductance). Time between the procedure and the reference standard is short enough (for each of the 40 patients two time periods were selected. The first two minutes (baseline) were compared to the timeframe when the anaesthesia was administered (minutes 12 to 14). FLACC scale was used to rate pain during the anaesthetic moment and HR and skin conductance were used before and during the procedure). All patients received the same tests. Study has blind conditions (results were blinded as both groups, experimental and control, were asked to use headphones in order to maintain blind conditions to the evaluators). Clinical data were available when results were interpreted (age of the patients, propose of intervention: dental anaesthetic infiltration, patients: healthy children that must have never received dental care).There are no uninterpretable results and it is clear what happened with all patients (no withdrawals).
11.5 Quality of evidence assessment
The quality of the evidence of the studies has been assessed using GRADE criteria. Possible outcomes and their interpretations are reflected in Table 6 (25). Each article has been studied for evidence individually in a step-by-step way and results have been systematized in the following Table
9.
Table 9. Summary of Findings (SoF table)
Study design Risk of bias Inconsis tency Indirect ness Imprecis ion Publicat ion bias Other (upgra ding factors ) Quality of evidence Oliveira et al. (12) RCT (starts as HIGH quality) No No Serious (-1) Serious (-1) Strongly suspecte d (-1) No +++ MODERATE Canbulat et al. (30) RCT (starts as HIGH quality) No No Serious (-1) Serious (-1) Strongly suspecte d (-1) No +++ MODERATE Weintrau b et al. Non-RCT (starts as Serious (-1) No Very serious Serious (-1) Strongly suspecte No ++ LOW
31 (31) LOW quality) (-2) d (-1) Ramírez et al. (32) RCT (starts as HIGH quality) No No Serious (-1) Serious (-1) Strongly suspecte d (-1) No +++ MODERATE
Oliveira et al. (12) is rated as MODERATE quality of evidence. It is a RCT, which is criterion that makes it to be considered as HIGH evidence but, due to indirectness (only children from 0-18 years old are included and intervention must be an acute procedure), imprecision (total number of events is less than 400) and publication bias (results come from a small study) it has been downgraded as each item lowers (-1). There are no reasons to upgrade the evidence, as it is very rare in RCTs that have been downgraded.
Canbulat et al. (30) is rated also as MODERATE quality of evidence. It is similar than previous one; it is a RTC, which is HIGH evidence however it has lower degree evidence due to some level of indirectness (-1) in population: only children are included (0-18 y.o.) and in intervention: only acute procedures (phlebotomy). Also, it has been downgraded by (-1) in imprecision as the total number of events is less than 400 and in publication bias (-1) as it is a small study. There are no reasons to upgrade the evidence, as it is very rare in RCTs that have been downgraded.
Weintraub et al. (31) is rated as LOW quality of evidence. As it is a non-RCT, its baseline level of evidence is already LOW. Criteria that make it LOW are the following: risk of bias (-1) (using QUADAS instrument it was classified as intermediate risk of bias), very serious indirectness (-2) (population included only children from 0-18 y.o., only patients with a single disease (JIA) and intervention was based only on acute procedures). Also, it has been downgraded by (-1) in imprecision as the total number of events is less than 400 and in publication bias (-1) as it is a small study. Furthermore, there are no reasons to upgrade the evidence.
Ramírez et al. (32) is rated as MODERATE quality of evidence. It is a RCT, which is criterion that makes it to be considered as HIGH evidence however there are some criteria that lower its evidence: indirectness (-1): population accepted were only children from 0-18 y.o., who must have never received dental care and intervention includes only acute procedure which involves a local anesthetic. Imprecision (-1): as the information is likely to be insufficient as the total number of events is less than 400. In addition, it has been downgraded by (-1) due to publication bias as it is a small study. There are no reasons to upgrade the evidence, as it is very rare in RCTs that have been downgraded.
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12. DISCUSSION
The results of this systematic review support the idea that non-pharmacological treatment is effective in reducing pain perception during acute painful procedures carried out in children. The non-pharmacological options discussed in these studies are methods based on distraction. The mechanism of action of these distractors pursues to shift the attention of the child from the procedure in order to diminish pain sensation. Thereby, distraction techniques reported in these articles are widely different one from others but being all effective: animated short films (12), distraction cards and kaleidoscope (30), medical clowns (31) and hypnosis (32). Furthermore, these alternative treatment options in comparison to pharmacological ones are accessible to all children, economical, they can be used indistinctly of the diagnosis and reusable. These advantages make them a good option in the treatment algorithm. They should be adopted by paediatricians as well as nurses and others health care at the beginning of pain management process.
Despite of the evidence of effectiveness of the non-pharmacological treatments as an alternative in pain management, the topic is still unknown and there are studies lacking about possible non-pharmacological options and evidence supporting its efficacy. Moreover, in most of the health centres such methods are not still included in the daily practice, and pain is alleviated in a conventional way using drugs as first option.
Summary of evidence
All four studies analysed shared the same aim, i.e.: to study a non-pharmacological treatment option and demonstrate its efficacy.
Through the analysis process of the different articles selected for this systematic review, three of them (12)(30)(32) were concluded to have low risk of bias. This conclusion demonstrates their transparency and that there is no big deviation from the truth, demonstrating consistency of their results. Therefore, they provide clear impressions and medical conclusions. On the other hand, the last article (31) has intermediate risk of bias what renders less information regarding to its methodology and being its results as less consistent.
The quality of evidence of most of the articles (12)(30)(32) were concluded to have moderate evidence quality. As they are RCTs, their baseline rating is already high. Nevertheless, they were downgraded to intermediate due to the non-compliance of diverse criteria such as indirectness, imprecision and publication bias. On the other hand, the last one (31) is a non-RTC thus having
33 already a low evidence quality. This last article presents more risk of bias, indirectness, imprecision and publication bias.
In general, all studies provide reliable conclusions regarding the distraction methods and their efficacy in treating acute pain during procedures in children as none of them has high risk of bias.
Limitations
The main limitation in the presented studies is the size of the sample: the studies are carried out regarding only a small amount of patients. Also, the precision of the existing pain evaluation scales tools (scales) are limited. Majority of the selected studies are RCT, which decreases risk of bias. Nevertheless, the blinding process remains unclear (or it does not exist) in most of them as well as the reference/index tests used.
13. CONCLUSIONS
The current systematic review demonstrates that non-pharmacological treatment methods are effective in reducing sensation of pain. Articles analysed in this research share the same conclusion: the four different distractors chosen are all effective in reducing pain during acute procedures.
Audiovisual distraction is useful in reducing pain sensation when used during acute painful procedures. It was stated that those patients’ pain levels (pain evaluated through pain scales) under audiovisual distraction were lower compared to those who didn’t get it. Furthermore, it is even better if patients benefit from it during the first painful procedure as patient learns from this first distraction experience and this can be used during subsequent procedures. Distraction cards as well as kaleidoscope are also useful tools for reducing pain as they got lower pain levels compared to those children in who blood samples were taken without using these tools. In addition, medical clowns help to decrease pain sensitivity thanks to their active communication and direct interaction with a patient. Finally, hypnosis in combination with conventional behaviour management techniques during acute procedures have shown to reduce pain. The mixture of them makes patient to collaborate more with paediatrician and feel more comfortable during the painful procedure.
In conclusion, all results support the effectiveness of the named distraction methods when used as non-pharmacological treatment of pain during acute procedures. Besides they all are an easy, sparing-money, reusable and safe techniques. All the distraction techniques help not only a patient but parents and health-care providers benefit from it too. It leads to a better compliance of a patient and his/her parents or caregivers. Moreover, it can guarantee less complications and better procedural
34 outcomes. These alternative treatments can turn the aversive aspect of a painful experience into a more pleasant sensation thus reducing pain in the moment of the procedure as well as future fairs related to medical-setting care.
14. PRACTICAL RECOMMENDATIONS
It is admitted that pain is a common problem in children and adolescents as recent epidemiological studies have shown. The verification of these facts and the proof of the future impact that the painful experience has on the child's life, has undoubtedly increased the interest on paediatric pain. For this reason, good pain management during painful procedures is essential.
Effective pain relief during acute procedures involve procedural preplanning, pain assessment, parental training, prepared medical stuff and choosing the best possible pain management technique. It is crucial likewise to provide a child friendly and comfortable environment. Each child should be managed in an individual way in order to proportionate a pain treatment as accurately as possible as each one has his own features, such as: age, gender, pain threshold, past pain-related experiences, personality, pain-coping strategies, family influence and social environment.
In order to alleviate pain, we must consider both: non-pharmacological, pharmacological or combination options by assessing patient’s reaction and physiological signs. Non-pharmacological tools have proved its usefulness in reducing pain feeling at the beginning and at the end of the procedure so they should be included in paediatrician and nurses’ protocols. Such methods focused mainly on patient’s distraction can reduce the use of medication, its adverse effects and complications so they should be considered first-line step. Moreover, they are inexpensive, safe, reusable, accessible and they can be adapted individually.
Future studies in order to investigate and propose better acute non-pharmacological pain control should include RCTs, with bigger sample size and with precise tests in order to rate pain. Also, it is important to study carryover effects of distraction techniques during long period of time in order to state the impact on the future (physiological, psychological as well as behavioural) that pain has on children.
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