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NCT01503060 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01503060
Other study ID # 1000025726
Secondary ID
Status Recruiting
Phase Phase 3
First received December 29, 2011
Last updated November 9, 2015
Start date December 2011

Study information
Verified date November 2015
Source The Hospital for Sick Children
Contact Anna Taddio, PhD
Phone 416-813-6235
Email anna.taddio@sickkids.ca
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 352
Est. completion date
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Months to 15 Months
Eligibility Inclusion Criteria:

1. Healthy infants undergoing vaccination.

Exclusion Criteria:

1. preterm birth (<37 weeks gestation)

2. prior hospitalization/surgery (other than postnatal care),

3. documented/ suspected sensitivity/allergy to amide anaesthetics/vaccines,

4. mother plans to breastfeed or to use topical anesthetics or sugar water during injection.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Behavioral:
• Educational video - Active
The active video will instruct parents in techniques related to optimal infant soothing.
• 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
• Sucrose
Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination
• 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
• Lidocaine
Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination

Locations
Country Name City State
Canada Outpatient Clinic Toronto Ontario
Canada The Hospital for Sick Children Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hypersensitivity to pain This will be assessed by comparing the pain scores between each active group and the placebo group at 15 months At 15 month vaccination (Visit 5) No
Secondary Effectiveness of interventions This will be assessed by comparing the pain scores between groups At 2,4,6,12 month vaccinations (Visit 1-4) No
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