Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0190133718
Study information
Scientific title
Acronym
Study hypothesis
To compare two commonly used analgesic regimes, intravenous morphine versus intramuscular codeine, in controlling immediate post-operative pain following surgery for primary cleft palate repair.
Ethics approval
Not provided at time of registration
Study design
Comparative, randomised, controlled clinical study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cleft palate repair
Intervention
Infants received one of two analgesics intraoperatively for immediate postoperative pain relief. Morphine was given by intravenous injection and codeine by the intramuscular route.
Intervention type
Drug
Phase
Not Specified
Drug names
Morphine, codeine
Primary outcome measures
Pain scores in the immediate postoperative period for 2 hours following surgery - is morphine better/same/worse than established regimes?
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/10/2003
Overall trial end date
01/06/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Infants having primary cleft palate repair with informed parental consent to enter the study.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
30
Participant exclusion criteria
Does not comply with above inclusion criteria
Recruitment start date
01/10/2003
Recruitment end date
01/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Queen Victoria Hospital NHS Trust
East Grinstead
RH19 3DZ
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
Queen Victoria Hospital NHS Foundation Trust (UK)
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/17760494
Publication citations
-
Results
Fenlon S, Somerville N, Comparison of codeine phosphate and morphine sulphate in infants undergoing cleft palate repair., Cleft Palate Craniofac. J., 2007, 44, 5, 528-531, doi: 10.1597/06-206.1.