Rotavirus vs. Sucrose for Vaccine Injection Pain

Phase 3

• Conditions: Vaccination Pain Management
• Interventions: Drug: Rotavirus; Drug: Sucrose

• Registration Number: NCT02174705
• Lead Sponsor: Anna Taddio

Brief Summary

This randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to sugar water for reducing vaccine injection pain in infants.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-22
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-25
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15
• Primary Completion: 2015-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• healthy infants receiving rotavirus vaccine in conjunction with primary immunizations in the first 6 months of life

Exclusion Criteria

• impaired neurological development, history of seizures, sedatives or narcotics in preceding 24 hours, parent unable to use study tools, prior participation in the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotavirus	Rotavirus	Rotavirus prior to vaccine injections
Sucrose	Sucrose	Sucrose prior to vaccine injections

Primary Outcome Measures

Name	Time	Method
Distress	immediately after vaccinations in 15 seconds	Observer rated using the Modified Behavioral Pain Scale (0-10) after each injection and overall

Secondary Outcome Measures

Name	Time	Method
Distress	immediately after vaccinations in 1 minute	Parent rated distress after each injection using a Numerical Rating Scale (0-10)

Trial Locations

Locations (2)

Kindercare; 🇨🇦 Toronto, Ontario, Canada

Anna Taddio; 🇨🇦 Toronto, Ontario, Canada