Rotavirus vs. Sucrose for Vaccine Injection Pain

August 13, 2014 updated by: Anna Taddio

A Randomized Controlled Trial of Rotavirus Vaccine vs. Sugar Water for Vaccine Injection Pain Management in Infants

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5N 1A8
        • Recruiting
        • Kindercare
        • Contact:
          • Dan Flanders, MD
          • Phone Number: (416) 848-7665
        • Principal Investigator:
          • Dan Flanders, MD
      • Toronto, Ontario, Canada, M5S 3M2
        • Not yet recruiting
        • Anna Taddio
        • Principal Investigator:
          • Dan Flanders, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sucrose
Sucrose prior to vaccine injections
Drug: Sucrose
Sucrose 24% orally prior to vaccine injections
Active Comparator: Rotavirus
Rotavirus prior to vaccine injections
Drug: Rotavirus
Rotavirus vaccine orally prior to vaccine injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distress
Time Frame: immediately after vaccinations in 15 seconds
Observer rated using the Modified Behavioral Pain Scale (0-10) after each injection and overall
immediately after vaccinations in 15 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distress
Time Frame: immediately after vaccinations in 1 minute intervals for 2 minutes
Observer rated cry duration after vaccination
immediately after vaccinations in 1 minute intervals for 2 minutes
Distress
Time Frame: immediately after vaccinations in 1 minute
Immunizer rated distress after each injection using a Numerical Rating Scale (0-10)
immediately after vaccinations in 1 minute
Distress
Time Frame: immediately after vaccinations in 1 minute
Parent rated distress after each injection using a Numerical Rating Scale (0-10)
immediately after vaccinations in 1 minute

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: immediately after vaccinations in 5 minutes
Number of infants spitting up/gagging with administration of study liquid
immediately after vaccinations in 5 minutes
Satisfaction
Time Frame: immediately after vaccination in 1 minute
Parent rated satisfaction with pain control using likert scale
immediately after vaccination in 1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anna Taddio

Investigators

  • Principal Investigator: Anna Taddio, PhD, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

June 22, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 13, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 30427

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vaccination Pain Management

Clinical Trials on Sucrose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe