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

Phase 4

Completed

• Conditions: Cleft Palate Repair

• Registration Number: NCT00386269
• Lead Sponsor: Institute of Child Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-11
• Study Completion: 2007-09
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-28
• Last Update Posted: 2007-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Infants with cleft palate

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dose of morphine used within the first 6h after surgery

Secondary Outcome Measures

Name	Time	Method
Pain scores

Trial Locations

Locations (1)

Great Ormond Street Hospital, Anaesthetics; 🇬🇧 London, United Kingdom