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
  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
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:


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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on August 27, 2014