RT Journal Article
SR Electronic
T1 Relative effectiveness of additive pain interventions during vaccination in infants
JF Canadian Medical Association Journal
JO CMAJ
FD Canadian Medical Association
SP E227
OP E234
DO 10.1503/cmaj.160542
VO 189
IS 6
A1 Taddio, Anna
A1 Riddell, Rebecca Pillai
A1 Ipp, Moshe
A1 Moss, Steven
A1 Baker, Stephen
A1 Tolkin, Jonathan
A1 Malini, Dave
A1 Feerasta, Sharmeen
A1 Govan, Preeya
A1 Fletcher, Emma
A1 Wong, Horace
A1 McNair, Caitlin
A1 Mithal, Priyanjali
A1 Stephens, Derek
YR 2017
UL http://www.cmaj.ca/content/189/6/E227.abstract
AB 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.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 double-dummy 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