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

This study has been completed.
Information provided by:
Institute of Child Health Identifier:
First received: October 10, 2006
Last updated: November 28, 2007
Last verified: November 2007
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.

Condition Intervention Phase
Cleft Palate Repair
Drug: Codeine Phosphate Analgesia
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants

Resource links provided by NLM:

Further study details as provided by Institute of Child Health:

Primary Outcome Measures:
  • Dose of morphine used within the first 6h after surgery

Secondary Outcome Measures:
  • Pain scores

Estimated Enrollment: 44
Study Start Date: January 2004
Study Completion Date: September 2007

Ages Eligible for Study:   4 Months to 8 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Infants with cleft palate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00386269

United Kingdom
Great Ormond Street Hospital, Anaesthetics
London, United Kingdom, WC1N 1EH
Sponsors and Collaborators
Institute of Child Health
Principal Investigator: Mike Sury, Dr Institute Of Child Health and Great Ormond Street Hospital
  More Information

Responsible Party: Dr Tracy Assari, Institute of Child Health Identifier: NCT00386269     History of Changes
Other Study ID Numbers: 02AR53 
Study First Received: October 10, 2006
Last Updated: November 28, 2007
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Institute of Child Health:
codeine phosphate analgesia

Additional relevant MeSH terms:
Cleft Palate
Congenital Abnormalities
Craniofacial Abnormalities
Jaw Abnormalities
Jaw Diseases
Maxillofacial Abnormalities
Mouth Abnormalities
Mouth Diseases
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Stomatognathic Diseases
Stomatognathic System Abnormalities
Analgesics, Opioid
Antitussive Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents processed this record on May 26, 2016