Related Experiment Video
Updated: Mar 10, 2026

Electrophysiological Measurement of Noxious-evoked Brain Activity in Neonates Using a Flat-tip Probe Coupled to Electroencephalography
Published on: November 29, 2017
Relative effectiveness of additive pain interventions during vaccination in infants
Anna Taddio1, Rebecca Pillai Riddell2, Moshe Ipp2
1Leslie Dan Faculty of Pharmacy (Taddio, Fletcher, Wong, McNair, Mithal), University of Toronto; Child Health Evaluative Sciences (Taddio), The Hospital for Sick Children, Toronto, Ont.; Department of Psychology (Pillai Riddell), York University, North York, Ont.; Department of Psychiatry (Pillai Riddell) and Paediatrics (Ipp), University of Toronto, Toronto, Ont.; Pediatricians (Moss, Baker, Tolkin, Malini, Feerasta, Govan), North York, Ont.; Biostatistics and Data Analysis Unit (Stephens), The Hospital for Sick Children, Toronto, Ont. anna.taddio@utoronto.ca.
Insights
Topical liposomal lidocaine, combined with video education and sucrose, effectively reduced infant pain during vaccinations. This additive pain intervention strategy improved the vaccination experience for infants and parents.
Area of Science:
- Pediatric Pain Management
- Vaccination Adverse Events
- Clinical Trial Methodology
Background:
- Vaccine injections cause pain and distress in infants, potentially leading to vaccine hesitancy.
- Effective pain management during infant vaccinations is crucial for a positive healthcare experience.
Purpose of the Study:
- To compare the effectiveness of additive pain interventions during infant vaccinations.
- To evaluate combined interventions including video education, sucrose, and topical lidocaine.
Main Methods:
- A multicenter, double-blind, randomized controlled trial involving 352 infants.
- Infants received one of four pain management strategies: placebo, video, video+sucrose, or video+sucrose+lidocaine.
- Infant distress was assessed using the Modified Behavioural Pain Scale during pre-injection, injection, and recovery phases.
Main Results:
- The combination of video, sucrose, and liposomal lidocaine showed a trend towards lower needle pain scores (6.3 ± 0.8) compared to other groups (6.7 ± 0.8).
- No significant differences in pain scores were found between groups for baseline or recovery phases.
- Pain scores varied significantly across infant ages, with needle pain scores differing among intervention groups (p=0.003).
Conclusions:
- Liposomal lidocaine, as part of an additive pain intervention, provided consistent analgesia during infant vaccinations.
- This multimodal approach may help mitigate pain and distress associated with routine infant immunizations.
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.
Related Concept Videos
Analgesia and Pain Management
Local Anesthetics: Clinical Application as Epidural Anesthesia
Since epidural anesthetics can be infused through an epidural catheter, all types of drugs, including short-acting ones, can be administered. Chloroprocaine and lidocaine are examples of short and long-duration anesthetics, respectively. Bupivacaine...
Parenteral Anesthetics: Overview
Drug Dosing: Infants and Children

