Article

Effectiveness and tolerability of pharmacologic and combined interventions for reducing injection pain during rout in childhood immunizations: Systematic review and meta- analyses

Department of Paediatrics, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
Clinical Therapeutics (Impact Factor: 2.59). 01/2009; 31 Suppl 2:S104-51. DOI: 10.1016/j.clinthera.2009.08.001
Source: PubMed

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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    • "The primary outcome was maternal-reported utilization of breastfeeding, sugar water, and topical anaesthetics during routine 2-month infant vaccination. These interventions were selected because they are the most effective based on their effect sizes [3] [14] [17], yet the least used [9] [20] [21]. Based on a control group mean number of interventions = 0.1, SD = 0.3 [20], D = 0.5, intracluster correlation coefficient = 0.6 [2], a = 0.05, and b = 0.8, 136 participants were required, equivalent to 14 classes, with up to 10 participants/class. "
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    ABSTRACT: Educating parents about ways to minimize pain during routine infant vaccine injections at the point of care may positively impact on pain management practices. The objective of this cluster randomized trial was to determine the impact of educating parents about pain in outpatient pediatric clinics on their use of pain treatments during routine infant vaccinations. Four hospital-based pediatric clinics were randomized to intervention or control groups. Parents of 2- to 4-month-old infants attending the intervention clinics reviewed a pamphlet and a video about vaccination pain management on the day of vaccination, whereas those in the control clinics did not. Parent use of specific pain treatments (breastfeeding, sugar water, topical anesthetics, and/or holding of infants) on the education day and at subsequent routine vaccinations 2 months later was the primary outcome. Altogether, 160 parent-infant dyads (80 per group) participated between November 2012 and February 2014; follow-up data were available for 126 (79%). Demographics did not differ between groups (P > 0.05). On the education day and at follow-up vaccinations, use of pain interventions during vaccinations was higher in the intervention group (80% vs 26% and 68% vs 32%, respectively; P < 0.001 for both analyses). Educating parents about pain management in a hospital outpatient setting leads to higher use of pain interventions during routine infant vaccinations.
    Pain 01/2015; 156(1):185-91. DOI:10.1016/j.pain.0000000000000021 · 5.84 Impact Factor
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    • "The primary outcome was maternal-reported utilization of breastfeeding, sugar water, and topical anaesthetics during routine 2-month infant vaccination. These interventions were selected because they are the most effective based on their effect sizes [3] [14] [17], yet the least used [9] [20] [21]. Based on a control group mean number of interventions = 0.1, SD = 0.3 [20], D = 0.5, intracluster correlation coefficient = 0.6 [2], a = 0.05, and b = 0.8, 136 participants were required, equivalent to 14 classes, with up to 10 participants/class. "
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    ABSTRACT: Analgesic interventions are not routinely used during vaccine injections in infants. Parents report a desire to mitigate injection pain but lack the knowledge about how to do so. The objective of this cluster randomized trial was to evaluate the effect of a parent-directed prenatal education teaching module about vaccination pain management on analgesic utilization at future infant vaccinations. Expectant mothers enrolled in prenatal classes at Mount Sinai Hospital, Toronto were randomized to a 30-minute interactive presentation about vaccination pain management (experimental group) or general vaccination information (control group). Both presentations included a Powerpoint™ and video presentation, take-home pamphlet, and 'Question and Answer' period. The primary outcome was self-reported utilization of breastfeeding, sugar water or topical anesthetics at routine 2-month infant vaccinations. Between October, 2012 and July, 2013, 197 expectant mothers from 28 prenatal classes participated; follow-up was obtained in 174 (88%). Maternal characteristics did not differ (p>0.05) between groups. Utilization of one or more pre-specified pain interventions occurred in 34% of participants in the experimental group compared to 17% in the control group (p=0.01). Inclusion of a pain management module in prenatal classes led to increased utilization of evidence-based pain management interventions by parents at the 2-month infant vaccination appointment. Educating parents offers a novel and effective way of improving the quality of pain care delivered to infants during vaccination. Additional research is needed to determine if utilization can be bolstered further using techniques such as; postnatal hospital reinforcement, reminder cards, and clinician education.
    Pain 04/2014; 155(7). DOI:10.1016/j.pain.2014.03.024 · 5.84 Impact Factor
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    • "Administration of the vaccination is recommended before sexual debut in order to maximize the effectiveness of the immunization [2]. However, immunizations are the most common iatrogenic intervention posing a risk of pain for children [3], and the children's cognitive as well as emotional needs ought to be taken into consideration when planning for caring interventions related to immunizations. According to Galvin and Todres [4], caring can be divided into three domains: the head, the hand, and the heart. "
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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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