Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Comparative, randomised, controlled clinical study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Morphine, codeine
Primary outcome measure
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 study start date
01/10/2003
Overall study end date
01/06/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Infants having primary cleft palate repair with informed parental consent to enter the study.
Participant type(s)
Patient
Age group
Child
Sex
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
England, United Kingdom
Study 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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/09/2007 | Yes | No |