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

This study has been completed.

Sponsor:

Information provided by:

Institute of Child Health

ClinicalTrials.gov Identifier:

NCT00386269

First received: October 10, 2006

Last updated: November 28, 2007

Last verified: November 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

October 10, 2006

Last Updated Date

November 28, 2007

Start Date ^ICMJE

January 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Dose of morphine used within the first 6h after surgery

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00386269 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pain scores

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double

Condition ^ICMJE

Cleft Palate Repair

Intervention ^ICMJE

Drug: Codeine Phosphate Analgesia

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

September 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Infants with cleft palate

Sex/Gender

Sexes Eligible for Study:

All

Ages

4 Months to 8 Months (Child)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00386269

Other Study ID Numbers ^ICMJE

02AR53

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Dr Tracy Assari, Institute of Child Health

Study Sponsor ^ICMJE

Institute of Child Health

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mike Sury, Dr

Institute Of Child Health and Great Ormond Street Hospital

PRS Account

Institute of Child Health

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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