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A randomized trial of rotavirus vaccine versus sucrose solution for vaccine injection pain
Anna Taddio1, Daniel Flanders2, Eitan Weinberg2
1Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON, Canada M5S 3M2; Child Health Evaluative Sciences, The Hospital for Sick Children, 555 University Avenue, Toronto, ON, Canada M5G 1X8.
Insights
Oral rotavirus vaccine and sucrose solution offer similar pain relief for infants during vaccinations. Administering the rotavirus vaccine before injectable vaccines is recommended for infants aged 2 and 4 months.
Area of Science:
- Pediatric Pain Management
- Vaccine Administration
- Infant Analgesia
Background:
- Sucrose solutions are known analgesics for infants, commonly used to manage procedural pain.
- The oral rotavirus vaccine contains sucrose, raising questions about its potential analgesic properties.
- The comparative analgesic effectiveness of rotavirus vaccine versus sucrose solution is not well-established.
Purpose of the Study:
- To compare the analgesic effectiveness of oral rotavirus vaccine against a sucrose solution.
- To determine the optimal timing for administering rotavirus vaccine relative to injectable vaccines for pain management.
Main Methods:
- A randomized controlled trial involving 120 infants aged 2-4 months receiving rotavirus and injectable vaccines.
- Infants were randomized to receive either rotavirus vaccine first followed by sucrose, or vice versa.
- Pain was assessed using the Numerical Rating Scale (NRS) and Modified Behavioural Pain Scale (MBPS), along with cry duration.
Main Results:
- No significant differences in pain scores (MBPS, NRS) or cry duration were observed between the rotavirus vaccine and sucrose solution groups.
- Demographic characteristics, including age and sex, did not differ between the study groups.
- Pain scores for injection-induced pain were comparable regardless of whether rotavirus vaccine or sucrose was administered first.
Conclusions:
- Oral rotavirus vaccine demonstrated equivalent analgesic effects to sucrose solution in reducing injection-induced pain in infants.
- The study recommends administering the oral rotavirus vaccine prior to injectable vaccines for infants at 2 and 4 months of age.
- Findings support the use of rotavirus vaccine as a potential pain-reducing agent during routine infant immunizations.
Objective:
Sucrose solutions are analgesic in infants. Oral rotavirus vaccine contains sucrose, however, it is not known if it possesses analgesic properties. The objective was to compare the analgesic effectiveness of rotavirus vaccine to sucrose solution when administered prior to injectable vaccines.
Methods:
Infants 2-4 months of age receiving oral rotavirus vaccine and two separate injectable vaccines on the same day were randomized to rotavirus vaccine (Rotarix) first followed by the injectable vaccines and sucrose (Tootsweet) afterwards, or vice versa. Pain was assessed by blinded raters using the Numerical Rating Scale (NRS, range 0-10) (parents, clinicians), or Modified Behavioural Pain Scale (MBPS, range 0-10) and cry duration (observers). Data were analyzed using t-tests or χ(2)-tests; Bonferroni correction was applied to correct for multiple comparisons, as appropriate.
Results:
Altogether, 120 infants participated: 60 were randomized to rotavirus vaccine first. Groups did not differ in demographics, including; age (p=0.448) and sex (p=0.464). The mean pain score (standard deviation) for both vaccine injections did not differ between infants given rotavirus vaccine first versus sucrose solution first: observer MBPS, parent NRS and clinician NRS scores were 7.4 (1.6) vs. 7.7 (1.6), 4.9 (2.1) vs. 5.8 (2.1), and 4.2 (2.1) vs. 4.6 (2.2), respectively. Similarly, there was no difference between groups in cry duration.
Conclusion:
Rotavirus vaccine did not differ from sucrose solution in reducing injection-induced pain. Based on the findings, it is recommended that rotavirus vaccine be administered prior to injectable vaccines in infants aged 2 and 4 months.
