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ISRCTN
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ISRCTN25994117
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DOI
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10.1186/ISRCTN25994117
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A clinical trial as proof of principle of the analgesic effectiveness of cannabinoids on postoperative pain
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Scientific title
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Acronym
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CANPOP
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Serial number at source
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G9901459
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Study hypothesis
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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
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Lay summary
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Postoperative pain
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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.
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Anticipated start date
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01/01/2001
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Anticipated end date
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12/04/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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400
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Interventions
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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
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Primary outcome measure(s)
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The primary outcome is the total pain relief score over 6 h based on hourly measurements from a verbal rating scale
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16645457
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Contact name
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Dr
Anita
Holdcroft
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Address
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Magill Department of Anaesthesia
Faculty of Medicine
Imperial College of Science, Technology and Medicine
Chelsea and Westminster Hospital
369 Fulham Road
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City/town
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London
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Zip/Postcode
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SW10 9NH
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Country
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United Kingdom
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Tel
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+44 (0)20 8746 8026
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Fax
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+44 (0)20 8746 8801
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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23/10/2000
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Last edited
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07/09/2009
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Date ISRCTN assigned
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23/10/2000
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