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

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

This study has been completed.

Sponsored by:	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

Genetics Home Reference related topics:

Baller-Gerold syndrome Crouzon syndrome

MedlinePlus related topics:

Cleft Lip and Palate

ChemIDplus related topics:

Codeine Codeine phosphate

U.S. FDA Resources

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

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

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

Keywords provided by Institute of Child Health:

codeine phosphate analgesia

Study placed in the following topic categories:

Mouth Diseases

Craniofacial Abnormalities

Maxillofacial Abnormalities

Codeine

Musculoskeletal Abnormalities

Cleft Palate

Naphazoline

Oxymetazoline

Musculoskeletal Diseases

Guaifenesin

Phenylephrine

Stomatognathic Diseases

Phenylpropanolamine

Congenital Abnormalities

Additional relevant MeSH terms:

Respiratory System Agents

Physiological Effects of Drugs

Jaw Diseases

Stomatognathic System Abnormalities

Central Nervous System Depressants

Narcotics

Pharmacologic Actions

Mouth Abnormalities

Sensory System Agents

Therapeutic Uses

Jaw Abnormalities

Analgesics

Peripheral Nervous System Agents

Antitussive Agents

Central Nervous System Agents

Analgesics, Opioid

ClinicalTrials.gov processed this record on October 10, 2008