NCT02174705

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 15, 2014

Status Verified

August 1, 2014

Enrollment Period

1.3 years

First QC Date

June 22, 2014

Last Update Submit

August 13, 2014

Conditions

Vaccination Pain Management

Keywords

vaccinationpain managementsucroserotavirus

Outcome Measures

Primary Outcomes (1)

  • Distress

    Observer rated using the Modified Behavioral Pain Scale (0-10) after each injection and overall

    immediately after vaccinations in 15 seconds

Secondary Outcomes (3)

  • Distress

    immediately after vaccinations in 1 minute intervals for 2 minutes

  • Distress

    immediately after vaccinations in 1 minute

  • Distress

    immediately after vaccinations in 1 minute

Other Outcomes (2)

  • Safety

    immediately after vaccinations in 5 minutes

  • Satisfaction

    immediately after vaccination in 1 minute

Study Arms (2)

Sucrose

EXPERIMENTAL

Sucrose prior to vaccine injections

Drug: Sucrose

Rotavirus

ACTIVE COMPARATOR

Rotavirus prior to vaccine injections

Drug: Rotavirus

Interventions

SucroseDRUG

Sucrose 24% orally prior to vaccine injections

Sucrose
RotavirusDRUG

Rotavirus vaccine orally prior to vaccine injections

Rotavirus

Eligibility Criteria

Age2 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kindercare

Toronto, Ontario, M5N 1A8, Canada

RECRUITING

Anna Taddio

Toronto, Ontario, M5S 3M2, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Anna Taddio, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Taddio, PhD

CONTACT

416-978-8822anna.taddio@utoronto.ca

Moshe Ipp, MD

CONTACT

416-924-7171mm.ipp@utoronto.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2014

First Posted

June 25, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2016

Last Updated

August 15, 2014

Record last verified: 2014-08

Locations

CA(2)