Rotavirus vs. Sucrose for Vaccine Injection Pain

Anna Taddio

Status and phase: Unknown; Phase 3

Conditions: Vaccination Pain Management

Treatments: Drug: Rotavirus; Drug: Sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT02174705

30427

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 2 to 6 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Sucrose

Experimental group

Description:

Sucrose prior to vaccine injections

Treatment:

Drug: Sucrose

Rotavirus

Active Comparator group

Description:

Rotavirus prior to vaccine injections

Treatment:

Drug: Rotavirus