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Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain

Primary Purpose

Pain

Status

Unknown status

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Educational video - Active

Educational Video - Sham

Sucrose Placebo (water)

Sucrose

Lidocaine Placebo

Lidocaine

About this trial

This is an interventional supportive care trial for Pain focused on measuring pediatrics, Pain, Immunization

Eligibility Criteria

2 Months - 15 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1. Healthy infants undergoing vaccination.

Exclusion Criteria:

preterm birth (<37 weeks gestation)
prior hospitalization/surgery (other than postnatal care),
documented/ suspected sensitivity/allergy to amide anaesthetics/vaccines,
mother plans to breastfeed or to use topical anesthetics or sugar water during injection.

Sites / Locations

Outpatient ClinicRecruiting
The Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Visit 1-4 (2,4,6,12 month vaccinations): Patients will receive standard care Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.

Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.

Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.

Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar water and a topical anesthetic Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.

Outcomes

Primary Outcome Measures

Hypersensitivity to pain

This will be assessed by comparing the pain scores between each active group and the placebo group at 15 months

Secondary Outcome Measures

Effectiveness of interventions

This will be assessed by comparing the pain scores between groups

Full Information

NCT ID

NCT01503060

First Posted

December 29, 2011

Last Updated

November 9, 2015

Sponsor

The Hospital for Sick Children

1. Study Identification

Unique Protocol Identification Number

NCT01503060

Brief Title

Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain

Official Title

Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain: A Longitudinal Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2011 (undefined)

Primary Completion Date

April 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to find out the effects of routinely using different types of pain-relieving strategies during routine immunization injections performed in infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain

Keywords

pediatrics, Pain, Immunization

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

352 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Placebo Comparator

Arm Description

Visit 1-4 (2,4,6,12 month vaccinations): Patients will receive standard care Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.

Arm Title

Group 3

Arm Type

Active Comparator

Arm Description

Arm Title

Group 4

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Educational video - Active

Intervention Description

The active video will instruct parents in techniques related to optimal infant soothing.

Intervention Type

Behavioral

Intervention Name(s)

Educational Video - Sham

Intervention Description

The sham video will provide general information about immunization immunization pain management.

Intervention Type

Drug

Intervention Name(s)

Sucrose Placebo (water)

Intervention Description

Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination

Intervention Type

Drug

Intervention Name(s)

Sucrose

Intervention Description

Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination

Intervention Type

Drug

Intervention Name(s)

Lidocaine Placebo

Intervention Description

Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Description

Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination

Primary Outcome Measure Information:

Title

Hypersensitivity to pain

Description

This will be assessed by comparing the pain scores between each active group and the placebo group at 15 months

Time Frame

At 15 month vaccination (Visit 5)

Secondary Outcome Measure Information:

Title

Effectiveness of interventions

Description

This will be assessed by comparing the pain scores between groups

Time Frame

At 2,4,6,12 month vaccinations (Visit 1-4)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Months

Maximum Age & Unit of Time

15 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. Healthy infants undergoing vaccination. Exclusion Criteria: preterm birth (<37 weeks gestation) prior hospitalization/surgery (other than postnatal care), documented/ suspected sensitivity/allergy to amide anaesthetics/vaccines, mother plans to breastfeed or to use topical anesthetics or sugar water during injection.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Taddio, PhD

Phone

416-813-6235

anna.taddio@sickkids.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Taddio, PhD

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

Facility Information:

Facility Name

Outpatient Clinic

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4V 2S2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Moshe Ipp, MD

Phone

(416) 924-7171

moshe.ipp@sickkids.ca

First Name & Middle Initial & Last Name & Degree

Moshe Ipp, MD

Facility Name

The Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5V1X8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Taddio, PhD

First Name & Middle Initial & Last Name & Degree

Anna Taddio, PhD

First Name & Middle Initial & Last Name & Degree

Moshe Ipp, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

28455250

Citation

Taddio A, Riddell RP, Ipp M, Moss S, Baker S, Tolkin J, Dave M, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. A Longitudinal Randomized Trial of the Effect of Consistent Pain Management for Infant Vaccinations on Future Vaccination Distress. J Pain. 2017 Sep;18(9):1060-1066. doi: 10.1016/j.jpain.2017.04.002. Epub 2017 Apr 26.

Results Reference

derived

PubMed Identifier

27956393

Citation

Taddio A, Riddell RP, Ipp M, Moss S, Baker S, Tolkin J, Malini D, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. Relative effectiveness of additive pain interventions during vaccination in infants. CMAJ. 2017 Feb 13;189(6):E227-E234. doi: 10.1503/cmaj.160542. Epub 2016 Dec 12.

Results Reference

derived

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Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain

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