NCT01503060

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 352 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 2 Months – 15 Months
• Healthy volunteers: Accepted

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

• Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-12-01
• Primary completion: 2016-04-01
• First posted: 2012-01-02
• Last updated: 2015-11-10

Locations

2 sites across 1 country: Canada