|
Main
|
|
Note: This record shows only 22 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: |
|
|
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:
|
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:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
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.
|
|
Source(s) of Monetary Support
|
|
Medical Research Council (MRC) (UK)
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|