Post-operative analgesic effects of an oral cannabinoid
| ISRCTN | ISRCTN05531690 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05531690 |
| Secondary identifying numbers | MCT-64678 |
- Submission date
- 24/02/2006
- Registration date
- 24/02/2006
- Last edited
- 24/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Pierre Beaulieu
Scientific
Scientific
CHUM - Hôtel-Dieu
Départment d'Anesthésiologie
3840, rue Saint-Urbain
Montreal
H2W 1T8
Canada
| Phone | +1 514 890 8000 X 14570 |
|---|---|
| pierre.beaulieu@umontreal.ca |
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 | Post-operative analgesic effects of an oral cannabinoid: an efficacy and dose-response randomised controlled study |
| Study objectives | 1. The major hypothesis is that nabilone decreases morphine consumption and nausea and vomiting following major surgery 2. The secondary objectives are to assess the anti-emetic effect of nabilone and to evaluate patients tolerability of the study medication |
| Ethics approval(s) | Comité d'éthique de la Recherche de l'Hôtel-Dieu du CHUM Montréal approved on the 25th August 2003 |
| Health condition(s) or problem(s) studied | Post-operative pain (in major orthopaedic, gynaecologic, abdominal and plastic procedures) |
| Intervention | Group A: 1 mg nabilone, one capsule of 1 mg + one capsule of placebo, 8 hourly Group B: 2 mg nabilone, two capsules of 1 mg, 8 hourly Group C: 50 mg ketoprofen, one capsule of 50 mg + one capsule of placebo, 8 hourly Group D: placebo, two capsules of placebo, 8 hourly Trial details received: 12 September 2005 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nabilone, ketoprofen |
| Primary outcome measure | A total (24 hours) morphine Patient Controlled Analgesia (PCA) consumption hours. |
| Secondary outcome measures | 1. Pain intensity as measured by the Visual Analogue Scale (VAS) 2. Anti-emetic properties of nabilone 3. Assessment of mood and anxiety prior to surgery 4. Time to discharge criteria as indices of post-operative recovery 5. Quality of sleep 6. Incidence of side effects such as sedation, euphoria ('high'), psychotic episodes |
| Overall study start date | 01/10/2003 |
| Completion date | 30/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 152 |
| Key inclusion criteria | 1. Patients 18 - 75 years old, either sex, scheduled for major orthopaedic surgery 2. Patients using a morphine patient controlled analgesia (PCA) device post-operatively 3. Patients should be American society of Anaesthesiology (ASA) pre-operative status I, II or III 4. Patients willing and able to give written informed consent |
| Key exclusion criteria | 1. Patients using cannabis or other substance of abuse, alcoholism 2. Patients where morphine is not the drug of choice for PCA 3. Patients with planned concomitant medication during the study with any of the following: non-steroidal anti-inflammatory drugs, acetaminophen, more than 300 mg acetyl salicylic acid per day, sedatives, anticonvulsants, antidepressants 4. Patients with ischaemic heart disease, cardiac arrhythmias failure 5. Patients with history of gastric or duodenal ulcer, renal insufficiency or asthma 6. Patients with chronic pain conditions and/or patients receiving chronic opioid therapy 7. Patients with history of psychiatric illness 8. Pregnant or lactating women |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 30/04/2005 |
Locations
Countries of recruitment
- Canada
Study participating centre
CHUM - Hôtel-Dieu
Montreal
H2W 1T8
Canada
H2W 1T8
Canada
Sponsor information
Hôtel-Dieu de Montréal (Canada)
Hospital/treatment centre
Hospital/treatment centre
3840 rue St-Urbain
Montréal
H2W 1T8
Canada
"ROR" |
https://ror.org/0468gx405 |
|---|
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-64678)
No information available
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 | 01/08/2006 | Yes | No |
