Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0012128260
Study information
Scientific title
Double-blind randomised study into the efficacy of codeine phosphate analgesia after cleft palate repair in infants
Acronym
Study hypothesis
How effective is codeine phosphate after cleft palate repair in infants and how much is metabolised to morphine in this age group?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Cleft palate repair
Intervention
1. Codeine phosphate after cleft palate repair
2. No codeine phosphate
Intervention type
Drug
Phase
Not Applicable
Drug names
Codeine phosphate
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2003
Overall trial end date
31/08/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Children who have cleft palate
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/02/2003
Recruitment end date
31/08/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Great Ormond Street Hospital
London
WC1N 3JH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Great Ormond Street Hospital for Children NHS Trust/Institute of Child Health
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Association of Paediatric Anaesthetists
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary