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

This study has been completed.

First Received: October 10, 2006 Last Updated: 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:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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 Surgery

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

Keywords provided by Institute of Child Health:

codeine phosphate analgesia

Additional relevant MeSH terms:

Mouth Diseases
Respiratory System Agents
Craniofacial Abnormalities
Physiological Effects of Drugs
Jaw Diseases
Stomatognathic System Abnormalities
Maxillofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Mouth Abnormalities
Sensory System Agents
Therapeutic Uses
Jaw Abnormalities

Analgesics
Congenital Abnormalities
Analgesics, Opioid
Central Nervous System Depressants
Narcotics
Codeine
Pharmacologic Actions
Cleft Palate
Stomatognathic Diseases
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009