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


CONCLUSIONS
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.
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.
Anna
A
Taddio
KinderCare Pediatrics, 491 Eglinton Ave W, Toronto, ON, Canada M5 N 1A8.
Daniel
D
Flanders
KinderCare Pediatrics, 491 Eglinton Ave W, Toronto, ON, Canada M5 N 1A8.
Eitan
E
Weinberg
Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON, Canada M5S 3M2.
Supriya
S
Lamba
Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON, Canada M5S 3M2.
Charmy
C
Vyas
Faculty of Applied Science & Engineering, University of Toronto, 35 St. George Street, Toronto, ON, Canada M5S 1A4.
Andrew F
AF
Ilersich
Department of Paediatrics, The Hospital for Sick Children, Toronto, ON, Canada M5G 1X8.
Moshe
M
Ipp
Department of Paediatrics, The Hospital for Sick Children, Toronto, ON, Canada M5G 1X8.
Carol
C
McNair
D000284:Administration, Oral; D000700:Analgesics / Q000008:administration & dosage*; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007223:Infant; D007273:Injections, Intramuscular; D008297:Male; D010146:Pain / Q000517:prevention & control*; D010147:Pain Measurement; D010290:Parents; D022243:Rotavirus Vaccines / Q000008:administration & dosage*; D013395:Sucrose / Q000008:administration & dosage*; D014611:Vaccination; D014613:Vaccines, Attenuated / Q000008:administration & dosage
D000700:Analgesics; C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated; D013395:Sucrose
Infant; NCT02174705; Pain management; Rotavirus vaccine; Sucrose; Vaccination