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A Longitudinal Randomized Trial of the Effect of Consistent Pain Management for Infant Vaccinations on Future
Anna Taddio1, Rebecca Pillai Riddell2, Moshe Ipp3
1Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada; Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.
Insights
Consistent pain management during infant vaccinations did not show long-term benefits for future infant pain reactivity. This study found no significant difference in pain scores at 15 months, regardless of early interventions.
Area of Science:
- Pediatrics
- Pain Management
- Immunology
Background:
- Infant vaccinations are a common source of acute pain.
- Effective pain management during early procedures may influence future pain responses.
- Long-term effects of consistent pain interventions in infancy are not well-established.
Purpose of the Study:
- To determine if consistent pain management during infant vaccinations impacts future pain reactivity.
- To evaluate the long-term efficacy of various pain intervention strategies in infants.
Main Methods:
- A multicenter, longitudinal, double-blind, randomized controlled trial involving 352 healthy infants.
- Infants received one of four pain management regimens (placebo, video, sucrose, or lidocaine) for vaccinations in the first year.
- Pain reactivity was assessed at 15 months using the Modified Behavioural Pain Scale by a blinded researcher.
Main Results:
- No significant differences in pain scores were observed among the groups during baseline, needle injection, or recovery phases at 15 months.
- Infant characteristics did not differ significantly across the treatment groups.
- Pain scores ranged from 0-10 on the Modified Behavioural Pain Scale.
Conclusions:
- Consistent use of pain interventions during the first year of life did not demonstrate a long-term beneficial effect on infant pain responsivity.
- Findings suggest that early, consistent pain management strategies may not alter future pain reactivity in children.
- Results are relevant for clinicians and researchers evaluating pediatric pain interventions.
Abstract:
The objective was to determine if consistent pain management during vaccine injections has a beneficial effect on future infant pain reactivity. This was a multicenter, longitudinal, double-blind, double-dummy, add-on, randomized controlled trial. Healthy infants were randomized to 1 of 4 add-on pain management regimens for all vaccinations in the first year of life: 1) placebo control (standard care), 2) parent video education about infant soothing (video), 3) video and oral sucrose solution (sucrose), 4) video and sucrose and topical liposomal lidocaine (lidocaine). At 15-month vaccinations, all active pain interventions were administered (video and sucrose and lidocaine); however, individuals remained blinded to the original treatments given. Pain at 15 months was evaluated during 3 procedure phases (baseline, needle injection, and recovery) by a researcher unaware of group allocation using a validated measure, the Modified Behavioural Pain Scale (range, 0-10). Altogether, 352 infants participated; characteristics did not differ among groups (P > .05). Pain scores did not differ among groups during baseline (P = .642), needle injection (P = .739), or recovery (P = .750) phases. In conclusion, there was no evidence of a long-term benefit of consistent use of pain interventions in the first year of life on future infant pain responsivity at 15-month vaccinations.
Perspective:
This randomized controlled trial did not find a long-term benefit of consistent pain management during infant vaccinations on future infant pain responsivity at 15 months. The results are relevant to clinicians and researchers studying and evaluating pain interventions in children undergoing medical procedures.
