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

NCT01503060 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2015-11-10

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Educational video - Active

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

BEHAVIORAL

Educational Video - Sham

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

DRUG

Sucrose Placebo (water)

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

DRUG

Sucrose

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

DRUG

Lidocaine Placebo

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

DRUG

Lidocaine

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

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Anna Taddio, PhD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
15 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2016-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01503060 on ClinicalTrials.gov