Effectiveness and tolerability of pharmacologic and combined interventions for reducing injection pain during routine childhood immunizations: systematic review and meta-analyses.
ABSTRACT Immunization is the most common cause of iatrogenic pain in childhood. Despite the availability of various analgesics to manage vaccine injection pain, they have not been incorporated into clinical practice. To date, no systematic review has been published on the effectiveness of pharmacologic and combined interventions for reducing injection pain.
The objectives of this article were to assess the effectiveness and tolerability of various pharmacologic and combined interventions for reducing the pain experienced by children during immunization.
MEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials were searched to identify randomized controlled trials (RCTs) and quasi-RCTs pertaining to pharmacologic and combined interventions to reduce injection pain in children 0 to 18 years of age using validated child self-reported pain or observer-reported assessments of child pain and distress. We included trials that (1) investigated the effects of pharmacologic interventions (ie, topical local anesthetics, sweet-tasting solutions, vapocoolants, and oral analgesics [acetaminophen or ibuprofen]); (2) compared 2 different analgesic interventions; and (3) evaluated combinations of >or= 2 analgesic interventions, including breastfeeding. Meta-analyses were performed using a fixed-effects model.
Thirty-two studies, involving 3856 infants and children 2 weeks to 15 years of age, were included in this systematic review; 23 of these trials were included in meta-analyses. Ten trials, including 1156 infants and children, evaluated topical local anesthetics. In a meta-analysis of 2 trials, including 276 children, child self-reported pain ratings were lower in children who received topical local anesthetics than in those who received a placebo. The standardized mean difference (SMD) was -0.25 (95% CI, -0.49 to -0.01; P = 0.04). The use of topical local anesthetics was associated with less pain than was placebo in 4 trials (527 infants) based on the difference between Modified Behavioral Pain Scale scores (range, 0-10) before and after vaccination: the weighted mean difference (WMD) was -0.79 (95% CI, -1.10 to -0.48; P < 0.001) and the SMD was -0.43 (95% CI, -0.60 to -0.26; P = 0.001). Observer-rated pain, using visual analog scale (VAS) scores (range, 0-100 mm), was significantly lower (WMD, -16.56 mm; 95% CI, -22.11 to -11.01; P < 0.001; and SMD, -0.75; 95% CI, -1.00 to -0.49; P < 0.001). The number needed to treat (NNT) to prevent 1 child from having clinically significant pain, measured using the Faces Pain Scale (FPS; score, >-3), was 3.7 (95% CI, 2.5 to 7.7) from 1 study. Eleven trials (1452 infants and children) evaluated sweet-tasting solutions. In a meta-analysis of 6 studies (665 infants), administration of sucrose with or without non-nutritive sucking (NNS; use of a pacifier) was associated with less pain than no intervention or sterile water with or without NNS; the SMD was -0.56 (95% CI, -0.72 to -0.40; P < 0.001). Total cry duration was lower in infants who received sucrose than in those who received sterile water (WMD, -9.41 sec; 95% CI, -13.18 to -5.64; P < 0.001; and SMD, -0.43; 95% CI, -0.61 to -0.25; P < 0.001). The NNT to prevent 1 child from having clinically significant pain, using the Neonatal Infant Pain Scale (score, >3), was 1.4 (95% CI, 1.0 to 2.5). In 3 trials that evaluated sweet-tasting solutions longitudinally, administration of sucrose or glucose (vs sterile water, with or without NNS) was associated with reduced pain based on cry duration or the University of Wisconsin Children's Hospital Pain Scale (all, P < 0.05). Data were pooled for 2 studies conducted in 100 children who received a spray with a vapocoolant or placebo at the injection site before the procedure. Child self-rated pain (4-point scale) was lower in the group treated with the vapo-coolant (SMD, -0.43; 95% CI, -0.83 to -0.02; P = 0.04); significant heterogeneity was reported for this outcome (chi(2) = 5.51; P = 0.02; I(2) = 82%). In 2 studies (117 children), no significant difference was found between vapocoolants and typical care (no treatment) based on child self-reports; significant heterogeneity was reported for this outcome (chi(2) = 9.89; P = 0.02; I(2) = 90%). None of the studies identified in the literature search evaluated oral analgesics (acetaminophen or ibuprofen). Four studies (318 infants and children) compared 2 different analgesic interventions; there was insufficient evidence to suggest superiority of 1 intervention over another. Combinations of >or=2 analgesic interventions were more effective than the individual interventions used alone. Child self-reported pain ratings were combined for 4 studies (350 children); the SMD was -0.52 (95% CI, -0.73 to -0.30; P = 0.001). Data on cry duration were pooled for 3 studies (229 infants and children); the WMD was -18.87 seconds (95% CI, -32.05 to -5.69; P = 0.005). Parent-rated child pain (VAS) scores were combined for 3 studies (365 infants and children); the WMD was -15.66 mm (95% CI, -19.74 to -11.57; P < 0.001). Nurse- or physician-rated child pain (VAS) scores were combined for 3 studies (368 infants and children); the WMD was -17.85 mm (95% CI, -21.43 to -14.28; P < 0.001). In a meta-analysis of 4 studies (474 infants), infants who were breastfed before, during, and after the procedure had less pain than did those who were not breastfed (SMD, -2.03; 95% CI, -2.26 to -1.80; P < 0.001). A meta-analysis of 3 studies (344 infants) found a shorter cry duration for infants who were breastfed than for those who were not breastfed (WMD, -38.00 sec; 95% CI, -42.27 to -33.73; P < 0.001; and SMD, -2.00; 95% CI, -2.27 to -1.73; P < 0.001). The NNT to prevent 1 infant from having clinically significant pain, using the Facial Pain Rating Scale (pain vs no pain), was 7.7 (95% CI, 4.5 to 25.0) from 1 study.
Topical local anesthetics, sweet-tasting solutions, and combined analgesic interventions, including breastfeeding, were associated with reduced pain during childhood immunizations and should be recommended for use in clinical practice.
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ABSTRACT: Objectives. This randomized controlled trial evaluated the effectiveness, feasibility, and acceptability of parent participation (PP) in an evidence-based method to reduce the pain of prekindergarten immunizations. Methods. Healthy children aged 4 to 6 years were randomized to a multimodal distraction method during administration of routine vaccines with PP and 1 medical assistant (experimental group) or 2 medical assistants (standard-of-care comparison group). Children and parents rated the pain after injections, and a blinded observer coded children's pain from videotapes. Results. In all, 76 children participated. Despite group randomization, more children in the medical assistant-only group received a 3-injection series (25; 68%) than in the PP group (6 [15%], P = .001). After adjustment for this imbalance, child-reported pain was higher in the PP group compared with the medical assistant-only group (2.95 vs 1.75; F = 5.87; df = 1.66; d = 0.64; P < .02). There were no differences between groups for parent-reported and observer-rated measures of pain or in intervention fidelity, duration of procedure, or child or parent satisfaction. Conclusions. Although child-reported pain was higher for the PP group, the magnitude of the difference may not be clinically significant. PP was feasible and acceptable to both parents and children, did not take any longer, and reduced the need for additional medical personnel. Together, these data provide preliminary support for PP for prekindergarten immunization pain management. © The Author(s) 2014.Clinical Pediatrics 12/2014; 54(3). DOI:10.1177/0009922814561593 · 1.26 Impact Factor
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ABSTRACT: Needle fear is a common problem in children undergoing immunization. To ensure that the individual child's needs are met during a painful procedure it would be beneficial to be able to predict whether there is a need for extra support. The self-reporting instrument facial affective scale (FAS) could have potential for this purpose. The aim of this study was to evaluate whether the FAS can predict pain unpleasantness in girls undergoing immunization. Girls, aged 11-12 years, reported their expected pain unpleasantness on the FAS at least two weeks before and then experienced pain unpleasantness immediately before each vaccination. The experienced pain unpleasantness during the vaccination was also reported immediately after each immunization. The level of anxiety was similarly assessed during each vaccination and supplemented with stress measures in relation to the procedure in order to assess and evaluate concurrent validity. The results show that the FAS is valid to predict pain unpleasantness in 11-12-year-old girls who undergo immunizations and that it has the potential to be a feasible instrument to identify children who are in need of extra support to cope with immunization. In conclusion, the FAS measurement can facilitate caring interventions.03/2014; 2014:628198. DOI:10.1155/2014/628198
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ABSTRACT: BACKGROUND:Analgesic interventions are not commonly administered during childhood vaccination, despite the fact that two-thirds of children are afraid of needles and one-tenth are noncompliant with immunization.OBJECTIVE:To explore children’s experiences of vaccination and preferences for analgesia.METHODS:A total of 17 children (four to 14 years of age) at an independent school in Toronto (Ontario) participated in three focus-group interviews. The majority had previous experience with pain management interventions during vaccination. Thematic content analysis was used to analyze interview transcripts.RESULTS:The findings were categorized into three main themes: experience of vaccination; roles and responsibilities regarding pain management; and impact of pain management. Children easily recalled previous vaccinations and discussed fear and distress experienced by themselves and others. Children believed that parents and immunizers should prepare them ahead of time and use interventions to manage and monitor pain. They also wanted adults to support their efforts to lead pain management. Children discussed benefits of managing pain, including reduced unnecessary suffering, improved vaccination experience, reduced risk of developing needle fears and reduced noncompliant behaviours. They were knowledgeable about strategies for reducing pain including distraction, topical anesthetics and injection techniques. They contrasted vaccination with and without pain management, and indicated a preference for pain management.CONCLUSION:Children reported that managing vaccination pain is important and that analgesic interventions should routinely be used. Incorporating pain management in the process of vaccination has the potential to improve children’s experiences with vaccination and promote more positive attitudes and behaviours.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale / AMMI Canada 07/2014; 25(4):196-200. · 0.49 Impact Factor