A randomized trial of rotavirus vaccine versus sucrose solution for vaccine injection pain |
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| Institution: | 1. Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON, Canada M5S 3M2;2. Child Health Evaluative Sciences, The Hospital for Sick Children, 555 University Avenue, Toronto, ON, Canada M5G 1X8;3. KinderCare Pediatrics, 491 Eglinton Ave W, Toronto, ON, Canada M5 N 1A8;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;1. South African Tuberculosis Vaccine Initiative (SATVI), Department of Paediatrics and Child Health and Institute of Infectious Disease & Molecular Medicine, University of Cape Town, Cape Town, South Africa;2. KEMRI/CDC, Kisumu, Kenya;3. Centro de Investigação em Saúde de Manhiça (CISM), Manhiça, Mozambique;4. Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa;5. Aeras, Rockville, MD, USA;6. Crucell Holland BV, Archimedesweg 4-6, 2333 CN Leiden, The Netherlands;7. State University of New York at Stony Brook, Stony Brook, NY, USA;8. Faculty of Medicine, Universidade Eduardo Mondlane, Maputo, Mozambique;1. Division of HIV/AIDS Prevention, US Centers for Disease Control and Prevention, Atlanta, GA, USA;2. Kenya Medical Research Institute, Kisumu, Kenya;3. ICF International, Assigned to Division of HIV/AIDS Prevention, US Centers for Disease Control and Prevention, Atlanta, GA, USA;1. School of Nursing, Nanjing University of Chinese Medicine, Nanjing, China;2. Children’s Hospital of Nanjing Medical University, China;3. Binzhou Medical University Hospital, Binzhou, China;1. Cincinnati Children’s Hospital Medzical Center, University of Cincinnati, Cincinnati, OH, USA;2. Genocea Biosciences, Cambridge, MA, USA;3. Innovative Analytics, Kalamazoo, MI, USA;4. University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA, USA |
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| Abstract: | ObjectiveSucrose 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.MethodsInfants 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 χ2-tests; Bonferroni correction was applied to correct for multiple comparisons, as appropriate.ResultsAltogether, 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.ConclusionRotavirus 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. |
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| Keywords: | Rotavirus vaccine Sucrose Pain management Vaccination Infant |
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