A clinical trial as proof of principle of the analgesic effectiveness of cannabinoids on postoperative pain
| ISRCTN | ISRCTN25994117 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25994117 |
| Secondary identifying numbers | G9901459 |
- Submission date
- 23/10/2000
- Registration date
- 23/10/2000
- Last edited
- 07/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anita Holdcroft
Scientific
Scientific
Magill Department of Anaesthesia
Faculty of Medicine
Imperial College of Science, Technology and Medicine
Chelsea and Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
| Phone | +44 (0)20 8746 8026 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | CANPOP |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2001 |
| Completion date | 12/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Not Specified |
| Target number of participants | 400 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 12/04/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Magill Department of Anaesthesia
London
SW10 9NH
United Kingdom
SW10 9NH
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2006 | Yes | No |
