World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 13 January 2015
Main ID:  ISRCTN25994117
Date of registration: 23/10/2000
Prospective Registration: Yes
Primary sponsor: Medical Research Council (MRC) (UK)
Public title: A clinical trial as proof of principle of the analgesic effectiveness of cannabinoids on postoperative pain
Scientific title:
Date of first enrolment: 01/01/2001
Target sample size: 400
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN25994117
Study type:  Interventional
Study design:  Randomised controlled trial (Treatment)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Anita    Holdcroft
Address:  Magill Department of Anaesthesia Faculty of Medicine Imperial College of Science, Technology and Medicine Chelsea and Westminster Hospital 369 Fulham Road SW10 9NH London United Kingdom
Telephone: +44 (0)20 8746 8026
Email:
Affiliation: 
Key inclusion & exclusion criteria
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
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.

Age minimum:
Age maximum:
Gender: Not Specified
Health Condition(s) or Problem(s) studied
Postoperative pain
Surgery
Postoperative pain
Intervention(s)
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
Primary Outcome(s)
The primary outcome is the total pain relief score over 6 h based on hourly measurements from a verbal rating scale
Secondary Outcome(s)
Not provided at time of registration.
Secondary ID(s)
G9901459
Source(s) of Monetary Support
Medical Research Council (MRC) (UK)
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history