Rotavirus vs. Sucrose for Vaccine Injection Pain | NCT02174705

Studies
Rotavirus vs. Sucrose for Vaccine Injection Pain

NCT02174705

Sponsor

Anna Taddio

Status

Unknown status

Last Update Posted

Aug 15, 2014Estimated

Enrollment

120Estimated

Phase

Phase 3

Conditions

Vaccination Pain Management

Interventions

Sucrose
Rotavirus

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Sep 2015Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Jun 22, 2014

First Submission Date that Met QC Criteria

Jun 23, 2014

First Posted Date

Jun 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2014

Last Update Posted Date

Aug 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sucrose	Experimental	Sucrose prior to vaccine injections	Drug: Sucrose
Rotavirus	Active Comparator	Rotavirus prior to vaccine injections	Drug: Rotavirus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sucrose	Drug	Sucrose 24% orally prior to vaccine injections	Sucrose

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

6 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anna Taddio, PhD	Contact	416-978-8822		anna.taddio@utoronto.ca
Moshe Ipp, MD	Contact	416-924-7171		mm.ipp@utoronto.ca

Overall Officials

Name	Affiliation	Role
Anna Taddio, PhD	University of Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kindercare	Recruiting	Toronto	Ontario	M5N 1A8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013395	Sucrose

Ancestor Terms

ID	Term
D004187	Disaccharides
D009844	Oligosaccharides
D011134	Polysaccharides
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided