Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants

Cleft Palate Repair Clinical Trial

Official title:

Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386269
• Other study ID #: 02AR53
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2006
• Last updated: November 28, 2007
• Start date: January 2004
• Est. completion date: September 2007

Study information

• Verified date: November 2007
• Source: Institute of Child Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study examines the analgesic efficacy of codeine phosphate. It is compared to placebo in infants receiving morphine after surgery. Codeine may be effective enough to make morphine unnecessary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Months to 8 Months

Eligibility

Inclusion Criteria:

• Infants with cleft palate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Cleft Palate
• Cleft Palate Repair

Intervention

Drug:
• Codeine Phosphate Analgesia

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital, Anaesthetics	London

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Child Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose of morphine used within the first 6h after surgery
Secondary	Pain scores