Sweet‐tasting solutions for needle‐related procedural pain in children aged one to 16 years
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To determine if any sweet‐tasting solutions, including sucrose, fructose, glucose or artificial sweeteners, are analgesic during needle‐related procedures in children aged one to 16 years.
Secondly, to conduct subgroup analyses based on the type of painful procedure, the type of control intervention, the type of sweet‐tasting solution, the amount and concentration of sweet‐tasting solution and incidence of adverse events.
Background
Children of all ages are exposed to needle related painful procedures; during intramuscular injections for scheduled childhood immunizations, and medical procedures performed during the course of childhood illnesses. These procedures are known to be painful, resulting in anxiety, distress and fear in children as well as their parents, and the risk of longer term fears of needle pain, parental non‐adherence with vaccination administration and avoidance of medical care (Schechter 2007; Taddio 2007). It is important that effective pain management strategies are consistently utilized in all settings where immunizations and other needle related procedures take place. A recent literature review identified ten published randomized, controlled trials (RCTs) of sweet solution analgesia which included infants beyond the neonatal period of 28 days of life, and three studies which included children (Harrison 2008). The review highlighted conflicting results between studies, but showed overall that sucrose or other sweet solutions continue to provide some analgesia in infants up to 12 months of age during painful procedures, although the effects may be less marked. There was less conclusive evidence to support the use of sweet solutions during painful procedures in children.
Description of the condition
Children undergo minor painful procedures such as blood collection and immunization. Provision of appropriate and effective analgesia for these procedures is of utmost importance. Untreated pain as a result of medical procedures not only results in immediate pain, distress and anxiety at the time of procedure, but has the potential to lead to longer term sequale, including increased pain at a subsequent procedures and fears of needle pain (Schechter 2007; Taddio 2007).
Description of the intervention
A large number of studies, reviews and systematic reviews show that sweet‐tasting solutions provide effective analgesia during minor painful procedures in neonates (postnatal age maximum of 28 days corrected for postmenstrual age) (Stevens 2010; Tsao 2007). Although sucrose has been the most frequently studied sweet solution (Stevens 2010), various alternative sweet solutions have been included in studies, including glucose, fructose, glycerine, honey, and non sucrose artificial sweeteners (Tsao 2007). The administration of sweet solutions is now widely recommended for routine use during painful procedures in neonates (AAP 2001; Anand 2001, Harrison 2006; Henderson‐Smart 2007; RACP 2005). The analgesic effect of sweet‐tasting solutions on neonates is well‐established, and there is growing evidence of analgesic effects in infants up to 12 months of age (Harrison 2008). However little is known about whether sweet solutions can help relieve procedural pain in children beyond one year of age.
How the intervention might work
The mechanisms of sweet taste induced analgesia are thought to be mediated by endogenous opioid systems (Blass 94). All sweet solutions may be effective in promoting calm in crying infants, and reducing procedural related pain, however sweeter tasting sugars of sucrose and fructose, are more effective than the less sweet‐tasting sugars of glucose and lactose (Blass and Smith 1992).
Why it is important to do this review
Since the publication of the narrative literature review (Harrison 2008), there has been much debate about the effectiveness of sweet‐tasting solutions in young children. A formal systematic review of all trials, both published and unpublished, is warranted to ascertain the efficacy of sweet solutions during needle‐related procedures in children aged one to 16 years.
Objectives
To determine if any sweet‐tasting solutions, including sucrose, fructose, glucose or artificial sweeteners, are analgesic during needle‐related procedures in children aged one to 16 years.
Secondly, to conduct subgroup analyses based on the type of painful procedure, the type of control intervention, the type of sweet‐tasting solution, the amount and concentration of sweet‐tasting solution and incidence of adverse events.
Methods
Criteria for considering studies for this review
Types of studies
RCTs, and quasi‐randomized, controlled trials. No language restrictions will be imposed.
Types of participants
Children aged one to 16 years undergoing needle‐related procedures. These procedures will include, but are not limited to: venepuncture, heel lance, finger lance, subcutaneous or intramuscular injection, lumbar puncture, supra‐pubic bladder aspiration. .
Types of interventions
Orally administered sweet‐tasting substances of any concentration and any volume, including sucrose, glucose, fructose and non‐sucrose sweeteners. Breastfeeding, breast milk or formula will not be considered as sweet solutions.
Solutions may be self administered or delivered orally by any means (syringe, dropper, gauze‐soaked pacifier, bottle) with or without a pacifier (non‐nutritive sucking on a soother) and with or without additional comfort measures such as cuddling, holding, being spoken to), distraction methods, such as use of toys, visual or verbal distraction (Uman 2006), or pharmacological strategies such as topical anaesthetic agents.
Acceptable interventions in the control group: Oral administration of; water, milk (formula, breast milk or breast fed), or other non‐sweet substances. In addition, use of pacifiers, positioning, cuddling, distraction, topical anaesthetic agents may be used.
All settings where sweet solutions are evaluated for pain reduction during needle related procedures will be included. These may include hospital, outpatient, community or school settings.
Types of outcome measures
Primary outcomes
Pain intensity assessed by a validated uni‐dimensional, multidimensional and/or composite pain score (including a combination of behavioural, physiological and contextual indicators), or self report of pain.
Secondary outcomes
-
Personnel pain scores such as those scored by parents, clinicians, and research staff.
-
Physiological responses such as heart rate, heart rate variability, respiratory rate, TcpO2, TcpCO2, SpO2, skin conductance.
-
Individual behavioural parameters such as crying characteristics, facial or body actions.
-
Other clinically important outcomes identified in individual studies (not prespecified).
-
Adverse events.
-
Choking, spitting up, and vomiting.
As we cannot predict all possible adverse effects of sweet‐tasting substances, we will report on any adverse effects/events described by the authors
Time(s) of measurement:
Timing of measurements and aggregation of data will vary from study to study. Common times of measurement:
-
baseline prior to delivery of intervention/control;
-
upon commencement of procedure;
-
30 and 60 seconds following commencement of procedure;
-
throughout entire duration of procedure;
-
up to 10 minutes following completion of procedure.
Search methods for identification of studies
The systematic review will follow the standard search strategy methods outlined by The Cochrane Collaboration (RevMan 5.0.0 User Guide, 2007).
No language restrictions will be applied.
Publications in abstract form only will not be included in the review, but will be listed in excluded studies. Authors of abstracts which have not been reported as full text articles will be contacted to provide unpublished data if acceptable to the authors.
Electronic searches
Searches will be conducted in the following databases available on the OvidSP interface: Cochrane Register of Controlled Trials (CCTR), MEDLINE, EMBASE, PsycINFO, ACP Journal Club, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects (DARE), Cochrane Methodology Register, Health Technology Assessment, and the NHS Economic Evaluation Database, and on the EBSCOhost interface: CINAHL. No language or document type restrictions will be applied.
The multipurpose search command (.mp.) on the OvidSP interface, and the All Text [Word Indexed] field code (TX) on the EBSCOhost interface will be used to search both text words and database subject headings (e.g. MeSH). To capture variations in suffix endings, the unlimited truncation symbol '*' will be used in both interfaces.
All searches will be conducted as far back as referenced, to March 2010.
The search terms and strategies for each database are listed in the 4 Appendices.
Searching other resources
A search will be conducted of personal files, relevant bibliographies, relevant recent neonatal, paediatric and pain journals, and paediatric and paediatric pain conference proceedings.
Data collection and analysis
Selection of studies
Two independent review authors will screen abstracts to identify eligible studies. Studies including children aged one to 16 years, undergoing a needle related painful procedure following receiving a sweet‐tasting solution will be considered for inclusion. The reviewers will also search other resources for relevant abstracts and articles. Full text articles of all potentially relevant abstracts will be retrieved and independently assessed for inclusion by the review authors. All discrepancies will be resolved through a consensus process.
Data extraction and management
Data extracted from each study will include: study design, age, overall sample size, sample size per group, number of groups, painful procedure, number of interventions, type of sweet solution(s), concentration of solution(s), volume of solution(s), outcomes, and adverse events. Two review authors will independently extract data from the studies using a standardized data extraction form. Differences will be resolved through a consensus process or by a third review author when necessary.
Assessment of risk of bias in included studies
Standard methods of the Cochrane Collaboration will be used to assess the methodological quality of the studies included in the review, addressing potential biases using a six point scale (Higgins 2008), using the following criteria: randomization generation; concealment of allocation, blinding of intervention; incomplete outcome data reported; selective outcome reporting; other sources of bias. Possible answers to these questions will be Yes, No, Can’t tell. The methodological quality of each study will be assessed independently by two raters. Differences will be resolved by discussion or a third review author, if necessary. The review author will not be blinded to authors or institutions.
Measures of treatment effect
RevMan 5.0, as provided by The Cochrane Collaboration, will be used. The mean scores and their standard deviations in the treatment and control groups will be extracted.
Unit of analysis issues
If the data are not presented in a format that allows for their use in the statistical package of RevMan 5.0 (too sparse, low quality or heterogeneous, or provided in graphic form only), then the data will be reported in narrative form only. Efforts will be made to obtain data from authors in a format that can be used in the statistical package in RevMan 5.0.
Dealing with missing data
Attempts will be made to contact the authors in case of missing information/data, or for data clarification, for the purposes of both data extraction and assessment of risk‐of‐bias.
Assessment of heterogeneity
In‐between‐study heterogeneity will be reported including the I‐squared (I2) test (Higgins 2002). Attempts will be made to try and explain the sources of in‐between‐study heterogeneity.
Assessment of reporting biases
Reporting biases will not be assessed
Data synthesis
A meta‐analysis will be performed if the data have been presented in sufficient information. Weighted mean difference (WMD) will be performed for used for continuous outcomes when interventions and outcomes of sufficient homogeneity are being analysed. Standardized mean difference (SMD) will be used for continuous outcomes when interventions and outcomes are heterogeneous. Relative risk (RR) and risk difference (RD) for dichotomous outcomes. If a statistically significant RD is identified, then the number needed to treat to benefit (NNTB) or the number needed to treat to harm (NNTH) will be calculated. The random‐effects model will be used.
Subgroup analysis and investigation of heterogeneity
Subgroup analysis may be performed according to procedure, age and type of sweet solution used.
Sensitivity analysis
Sensitivity analyses will be performed based on methodological quality, particularly randomization and blinding of trials.
