Condition category
Signs and Symptoms
Date applied
24/02/2006
Date assigned
24/02/2006
Last edited
24/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pierre Beaulieu

ORCID ID

Contact details

CHUM - Hôtel-Dieu
Départment d'Anesthésiologie
3840
rue Saint-Urbain
Montreal
H2W 1T8
Canada
+1 514 890 8000 X 14570
pierre.beaulieu@umontreal.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-64678

Study information

Scientific title

Post-operative analgesic effects of an oral cannabinoid: an efficacy and dose-response randomised controlled study

Acronym

Study hypothesis

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 patient’s tolerability of the study medication

Ethics approval

Comité d'éthique de la Recherche de l'Hôtel-Dieu du CHUM Montréal approved on the 25th August 2003

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Nabilone, ketoprofen

Primary outcome measures

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 trial start date

01/10/2003

Overall trial end date

30/04/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

152

Participant 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

Recruitment start date

01/10/2003

Recruitment end date

30/04/2005

Locations

Countries of recruitment

Canada

Trial participating centre

CHUM - Hôtel-Dieu
Montreal
H2W 1T8
Canada

Sponsor information

Organisation

Hôtel-Dieu de Montréal (Canada)

Sponsor details

3840 rue St-Urbain
Montréal
H2W 1T8
Canada

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-64678)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16873343

Publication citations

  1. Results

    Beaulieu P, Effects of nabilone, a synthetic cannabinoid, on postoperative pain., Can J Anaesth, 2006, 53, 8, 769-775, doi: 10.1007/BF03022793.

Additional files

Editorial Notes