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

This study has been completed.

First Received on October 10, 2006. Last Updated on November 28, 2007 History of Changes

Sponsor:	Institute of Child Health
Information provided by:	Institute of Child Health
ClinicalTrials.gov Identifier:	NCT00386269

Purpose

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 IV

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:

Genetics Home Reference related topics: Baller-Gerold syndrome Crouzon syndrome

MedlinePlus related topics: Cleft Lip and Palate

Drug Information available for: Codeine phosphate Codeine

U.S. FDA Resources

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

Eligibility

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

Criteria

Inclusion Criteria:

Infants with cleft palate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386269

Locations

United Kingdom
Great Ormond Street Hospital, Anaesthetics
London, United Kingdom, WC1N 1EH

Sponsors and Collaborators

Institute of Child Health

Investigators

Principal Investigator:

Mike Sury, Dr

Institute Of Child Health and Great Ormond Street Hospital

More Information

No publications provided

Responsible Party:	Dr Tracy Assari, Institute of Child Health
ClinicalTrials.gov 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
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities
Codeine

Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on February 12, 2012