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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00386269
First Posted: October 11, 2006
Last Update Posted: November 29, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institute of Child Health
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   4 Months to 8 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants with cleft palate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Dr Tracy Assari, Institute of Child Health
ClinicalTrials.gov Identifier: NCT00386269     History of Changes
Other Study ID Numbers: 02AR53
First Submitted: October 10, 2006
First Posted: October 11, 2006
Last Update Posted: November 29, 2007
Last Verified: November 2007

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
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents