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Vaccine. 2015 Jun 9;33(25):2939-43. doi: 10.1016/j.vaccine.2015.04.057. Epub 2015 Apr 24.

A randomized trial of rotavirus vaccine versus sucrose solution for vaccine injection pain.

Author information

1
Leslie 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. Electronic address: anna.taddio@utoronto.ca.
2
KinderCare Pediatrics, 491 Eglinton Ave W, Toronto, ON, Canada M5 N 1A8.
3
Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON, Canada M5S 3M2.
4
Faculty of Applied Science & Engineering, University of Toronto, 35 St. George Street, Toronto, ON, Canada M5S 1A4.
5
Department of Paediatrics, The Hospital for Sick Children, Toronto, ON, Canada M5G 1X8.

Abstract

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.

KEYWORDS:

Infant; NCT02174705; Pain management; Rotavirus vaccine; Sucrose; Vaccination

PMID:
25917674
DOI:
10.1016/j.vaccine.2015.04.057
[Indexed for MEDLINE]

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