Contact information
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9901459
Study information
Scientific title
Acronym
CANPOP
Study hypothesis
To determine if oral cannabinoids are analgesics and in the context of acute pain after surgery can provide pain relief. The primary outcome is the total pain relief score over 6 h based on hourly measurements from a verbal rating scale
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
Condition
Postoperative pain
Intervention
There are four groups with a single dose of one of the following administered at random:
1. Standardised cannabis plant extract
2. Tetrahydrocannabinol
3. Ibuprofen
4. Placebo
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
The primary outcome is the total pain relief score over 6 h based on hourly measurements from a verbal rating scale
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/01/2001
Overall trial end date
12/04/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Elective surgery for primary knee arthroplasties or gynaecological surgery (hysterectomies, myomectomies and tubal surgery). Written informed consent, cooperative, reliable, age 18-60 years, weight greater than or equal to 50 kg (July 2006: changed from 60 kg), able to take oral medication, at least moderate pain, approximately 24-48 h after surgery
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
400
Participant exclusion criteria
Preoperative pain medications. Analgesic drugs within 3 h of the study, surgical complications, haemorrhage (greater than 1000ml), ASA 3 or 4, any present or previous cardiovascular disease or medication, asthma, gastric ulcer, any present abnormal liver or renal function (as determined by laboratory tests), cannabis users within a month of the surgery, patients using sedatives, tranquillisers or anxiolytics, history of psychosis, pregnant (screening by pregnancy test) or lactating women, participation in a clinical study in the previous month and patients previously entered into this study.
Recruitment start date
01/01/2001
Recruitment end date
12/04/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Magill Department of Anaesthesia
London
SW10 9NH
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
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
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16645457
Publication citations
-
Results
Holdcroft A, Maze M, Doré C, Tebbs S, Thompson S, A multicenter dose-escalation study of the analgesic and adverse effects of an oral cannabis extract (Cannador) for postoperative pain management., Anesthesiology, 2006, 104, 5, 1040-1046.