Elsevier

Vaccine

Volume 33, Issue 25, 9 June 2015, Pages 2939-2943
Vaccine

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

https://doi.org/10.1016/j.vaccine.2015.04.057Get rights and content

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 χ2-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.

Introduction

Over 90% of young children demonstrate severe distress during vaccine injections [1]. Pain treatments such as sucrose solution are uncommonly used [2], [3], [4], despite a plethora of evidence demonstrating effectiveness [5]. Inadequate pain management can lead to negative experiences with vaccination and parental non-compliance with vaccination schedules [6]. Parents are dissatisfied with current analgesic practices [2], [7] and when pain-relief is provided to their children, both parents and health care providers report better satisfaction with medical care [8]. Under-utilization of analgesics during vaccination is largely attributed to the additional time and resources needed to implement them [2]. Finding feasible and cost-neutral pain-reducing methods would therefore be of interest to both clinicians and parents.

Oral rotavirus vaccine was added to the immunization schedule in Canada in 2010 and is usually given in conjunction with injectable vaccines at 2 and 4 months of age. There has been no guidance provided to clinicians about the order of administration of the oral rotavirus vaccine relative to injectable vaccines given at the same time, resulting in variability in clinical practice. Some clinicians administer the vaccine after injectable vaccines once the infant is calm, asserting that injection-induced infant crying increases the risk of spitting up the vaccine. Others administer the vaccine prior to injectable vaccines, asserting that because the rotavirus vaccine contains sweet-tasting substances (1073 mg sucrose/1.5 mL (71.5%), Rotarix™ product monograph, GlaxoSmithKline) and sucrose is known to be analgesic in infants, it can provide analgesia during the injections.

Of available pain interventions, sucrose solution has been widely recommended for use in infants due to a robust evidence base supporting its effectiveness and widespread experience with its use in the hospital setting [9], [10]. At present, there are no studies that have evaluated the analgesic properties of rotavirus vaccine. If rotavirus vaccine is demonstrated to reduce vaccine injection-induced pain, the sequence of vaccine administration could be standardized to begin with rotavirus vaccine such that exogenous sweet-tasting solutions might not need to be given. The objective of this study was to compare the analgesic effectiveness of rotavirus vaccine to sucrose solution for reducing pain from vaccine injections in infants.

Section snippets

Study design, participants and setting

We conducted a randomized controlled trial including healthy infants attending an outpatient paediatric clinic (KinderCare) in Toronto, Canada. Infants between 2 and 4 months of age receiving oral rotavirus vaccine in conjunction with primary immunizations [i.e., Diphtheria, Tetanus and acellular Pertussis/Inactivated Polio/Haemophilus influenza type b (DTaP-IPV-Hib, Pediacel™) and Pneumococcal conjugate vaccine (PCV, Prevnar™)] were included. We excluded infants with impaired neurological

Participant flow

The study was conducted between July 30, 2014 and November 18, 2014. Of the 175 parents approached for participation, 120 (69%) agreed to participate. Non-participants did not differ from participants with respect to sex distribution and mean weight: 48% male vs. 53% male; p = 0.627, and 5.9 kg (standard deviation = 1.0) vs. 5.8 kg (1.0); p = 0.709, respectively. Altogether, 60 infants were randomized to rotavirus vaccine first and 60 to sucrose solution first. Outcome data were available in all 120

Discussion

Reducing vaccination pain has important implications for health outcomes in infants as untreated pain can lead to negative experiences with vaccination and parental non-compliance with future vaccinations [6]. This study compared the effectiveness of rotavirus vaccine, an oral vaccine currently co-administered with injectable vaccines, to oral sucrose solution, an established pain-reducing treatment for infant vaccinations [5]. The results demonstrated insufficient evidence of a difference

Funding source

No external funding was secured for this study. Sucrose 24% solution supplies for the trial were provided by Equinox at no charge to investigators. Equinox was not involved in any aspect of the study.

Contributions of authors

Anna Taddio conceptualized and designed the study, provided administrative and supervision for the study, carried out the analysis, drafted the initial manuscript, and approved the final manuscript as submitted.

Daniel Flanders, Eitan Weinberg, Carol McNair, and Moshe Ipp conceptualized and designed the study, assisted in the interpretation of data, reviewed and revised the manuscript, and approved the final manuscript as submitted.

Supriya Lamba, Charmy Vyas, and Andrew F Ilersich assisted in

Acknowledgements

We wish to thank all the parents who participated with their infants and the staff at KinderCare for assistance with aspects of data collection and analysis.

Conflict of interest statement

A Taddio received research funding from Pfizer and study supplies from Ferndale and Natus for a separate clinical trial related to vaccination pain. The other authors have no conflicts of interest relevant to this article to disclose.

References (16)

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