Relative effectiveness of additive pain interventions during vaccination in infants

Abstract

MethodsWe conducted a multicentre, longitudinal, double-blind, doubledummy, add-on, randomized controlled trial. Healthy infants receiving vaccinations in 3 pediatric outpatient clinics, including 7 physician practices in Toronto were eligible. We excluded infants born before 36 weeks' gestation, infants who had stayed in hospital outside of postnatal care, and infants who were allergic to amide ABSTRACT BACKGROUND: Vaccine injections can cause acute pain and distress in infants, which can contribute to dissatisfaction with the vaccination experience and vaccine hesitancy. We sought to compare the effectiveness of additive pain interventions administered consistently during vaccine injections in the first year of life. RESEARCH Relative effectiveness of additive pain interventions during vaccination in infantsAnna METHODS:We conducted a multicentre, longitudinal, double-blind, add-on, randomized controlled trial. Healthy infants were randomly assigned to 1 of 4 levels of pain management for all vaccine injections at 2, 4, 6 and 12 months: (i) placebo control; (ii) parent-directed video education about infant soothing; (iii) the video plus sucrose administered orally or (iv) the video plus sucrose plus liposomal lidocaine applied topically. All infants benefit from injection techniques that minimize pain. We used a doubledummy design; hence all parents watched a video (active psychological intervention or placebo) and all infants received oral solution (sucrose or placebo) and topical cream (lidocaine or placebo). We assessed infant distress during 3 phases -preinjection (baseline), vaccine injection (needle), and 1 minute postinjection (recovery) -using the Modified Behavioural Pain Scale (range 0-10). We compared scores between groups and across infant ages using a mixed-model repeated-measures analysis. RESULTS:A total of 352 infants participated in the study, from Jan. 17, 2012, to Feb. 2, 2016. Demographics did not differ among intervention groups (p > 0.05). Baseline pain scores did not differ among intervention groups (p = 0.4), but did differ across ages (p < 0.001). Needle pain scores differed among groups (p = 0.003) and across ages (p < 0.001). The mean (± standard deviation) needle score was 6.3 (± 0.8) in the video-sucrose-lidocaine group compared with 6.7 (± 0.8) in each of the other groups. There were no other between-group differences. Recovery scores did not differ among groups (p = 0.98), but did differ across ages (p < 0.001). INTERPRETATION:Only liposomal lidocaine provided consistent analgesia within an additive pain intervention regimen during vaccinations in infants. Trial registration: ClinicalTrials.gov, no. NCT01503060 RESEARCH E228CMAJ | FEBRUARY 13, 2017 | VOLUME 189 | ISSUE 6anesthetics or vaccines and for whom mothers planned to use topical anesthetics, sucrose or breast feeding during vaccinations. Infants were randomly assigned to 1 of 4 pain-relieving regimens for all vaccine injections in their first year of life: (i) placebo control; (ii) parent-directed video education about i...

A hospital-wide initiative to eliminate or reduce needle pain in children using lean methodology

“…Children and their parents/legal guardians had the option of declining any or all strategies, which included the following 14 : (1) “Numb the skin” (for children of 36-week corrected gestational age and older). We chose to use 4% lidocaine cream 63 or needle-less lidocaine application using a J-tip (sterile, single-use, disposable injector that uses pressurized gas to propel medication through the skin) 38 , 39 as topical anesthetics. (2) Sucrose 20 , 54 or breastfeeding 51 for infants 0 to 12 months.…”

Pain Experience in a US Children’s Hospital: A Point Prevalence Survey Undertaken After the Implementation of a System-Wide Protocol to Eliminate or Decrease Pain Caused by Needles

“…This large-scale initiative was the first of its kind worldwide to mandate offering 4 evidence-based practices for needle procedures to all patients (topical anesthetics, sucrose and/or breastfeeding [for infants], comfort positioning, and distraction). [26][27][28][29][30][31][32][33][34][35] After rollout in the outpatient laboratories in 2014 (30 000 children annually) and the medicalsurgical units, the remainder of the inpatient units, including all critical care areas, joined the campaign in 2015. At the time the current study was conducted, all inpatient units had implemented the initiative, but were in various stages of adoption.…”

Reatividade à dor na vacinação de lactentes entre dois e cinco meses de idade que receberam sacarose

“…Os autores discutem que, a literatura prévia é conflitante, pois não foi encontrada diferença entre o sexo por Stevens, Johnston e Horton (1994), ao avaliarem fatores que, influenciam a resposta comportamental à dor em prematuros. Guinsburg et al (2000) TADDIO et al, 2017) ou mesmo dar preferência, sempre que possível, ao uso da amamentação (HARRISON et al, 2016;TADDIO et al, 2015;WHO, 2015), e, ainda o contato pele a pele, para a vacinação em idades mais precoces, ainda durante o primeiro mês de vida (JOHNSTON et al, 2017;TADDIO et al, 2015), destacando-se nessas duas últimas intervenções, além da eficácia comprovada, o fato de constituírem medidas naturais, sem custos adicionais, com interação intensa do binômio mãe-filho e potencial de ação mais prolongada por serem mantidas durante todo o procedimento doloroso até a recuperação.…”