Rotavirus vs. Sucrose for Vaccine Injection Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Vaccination Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sucrose

Sucrose prior to vaccine injections

Group Type EXPERIMENTAL

Sucrose

Intervention Type DRUG

Sucrose 24% orally prior to vaccine injections

Rotavirus

Rotavirus prior to vaccine injections

Group Type ACTIVE_COMPARATOR

Rotavirus

Intervention Type DRUG

Rotavirus vaccine orally prior to vaccine injections

Interventions

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Sucrose

Sucrose 24% orally prior to vaccine injections

Intervention Type DRUG

Rotavirus

Rotavirus vaccine orally prior to vaccine injections

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes