Rotavirus vs. Sucrose for Vaccine Injection Pain

• Sponsor: Anna Taddio (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02174705
• Collaborator: (none)
• Enrollment: 120
• Locations: 2
• Arms: 2
• Duration (Months): 27
• Patients Per Site: 60
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vaccination Pain Management	Drug: Sucrose; Drug: Rotavirus	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of Rotavirus Vaccine vs. Sugar Water for Vaccine Injection Pain Management in Infants
• Study Start Date: Jun 1, 2014
• Anticipated Primary Completion Date: Sep 1, 2015
• Anticipated Study Completion Date: Sep 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Distress [immediately after vaccinations in 1 minute intervals for 2 minutes]

   Observer rated cry duration after vaccination

2. Distress [immediately after vaccinations in 1 minute]

   Immunizer rated distress after each injection using a Numerical Rating Scale (0-10)

3. Distress [immediately after vaccinations in 1 minute]

   Parent rated distress after each injection using a Numerical Rating Scale (0-10)

Other Outcome Measures

1. Safety [immediately after vaccinations in 5 minutes]

   Number of infants spitting up/gagging with administration of study liquid

2. Satisfaction [immediately after vaccination in 1 minute]

   Parent rated satisfaction with pain control using likert scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 6 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kindercare	Toronto	Ontario	Canada	M5N 1A8
2	Anna Taddio	Toronto	Ontario	Canada	M5S 3M2

Sponsors and Collaborators

• Anna Taddio

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anna Taddio, Professor, University of Toronto
• ClinicalTrials.gov Identifier: NCT02174705
• Other Study ID Numbers: 30427
• First Posted: Jun 25, 2014
• Last Update Posted: Aug 15, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by Anna Taddio, Professor, University of Toronto: vaccination; pain management; sucrose; rotavirus

Study Results

No Results Posted as of Aug 15, 2014