Investigation of the Potentiation of the Analgesic Effects of Fentanyl by Ketamine in Humans: a Double-blinded, Randomised, Placebo Controlled, Crossover Study of Experimental Pain
| ISRCTN | ISRCTN83088383 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83088383 |
| Protocol serial number | MMC |
| Sponsor | Monash Medical Centre (Australia) |
| Funder | Monash Medical Centre |
- Submission date
- 10/04/2005
- Registration date
- 11/04/2005
- Last edited
- 07/01/2021
- 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 Adam Tucker
Scientific
Scientific
Dept Anaesthesia
Monash Medical Centre
246 Clayton Road
Clayton
3168
Australia
| Phone | +61 3 95946666 |
|---|---|
| adam.tucker@med.monash.edu.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Investigation of the Potentiation of the Analgesic Effects of Fentanyl by Ketamine in Humans: a Double-blinded, Randomised, Placebo Controlled, Crossover Study of Experimental Pain |
| Study objectives | The current investigation explored the interaction between ketamine and the opioid fentanyl in the anticipation that a low dose of ketamine might potentiate the analgesic effect of fentanyl. Furthermore, it was hypothesised that the interaction of these drugs might be associated with selective potentiation of analgesia without associated increased sedation; that is that potentiation might occur in the context of a very low dose of ketamine that was not otherwise associated with brain effects such as sedation. It was hoped that the identification of such doses of ketamine may enable better future management of both opioid sensitive physiological pain and NMDA receptor-mediated sensitisation without the disadvantage of increased sedation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pain |
| Intervention | The ten volunteers each attended five three-hour laboratory sessions on separate occasions. In each session, the volunteer received one of the following treatments: Placebo (saline) Propofol Ketamine Fentanyl Ketamine and Fentanyl Therefore, each volunteer was exposed to each of the five treatments, over five sessions, with the order of treatment randomised for each volunteer. During each session, the test battery was performed prior to drug administration as a measure of baseline and then repeated when the target concentrations were reached. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | ketamine, propofol, fentanyl |
| Primary outcome measure(s) |
Pain threshold to electrical current, pain threshold to contact heat, pain threshold to pressure, visual analogue scale for sedation, Observer Assessment of Alertness/Sedation Scale (OASS), Symbol Digit Modalities Test (SDMT), auditory reaction time |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | Ten healthy male volunteers were recruited via bulletin board advertisements. The volunteers were trained in the test procedures employed and medically screened. |
| Key exclusion criteria | Volunteers were excluded if they had a history of cardiac, neurological, or musculoskeletal disease. Other exclusion criteria included a history of drug abuse, pain syndromes, myasthenia gravis, acute narrow angle glaucoma, asthma, or heart failure, concurrent use of any analgesics, sedatives, erythromycin, monoamine oxidase (MAO) inhibitors, or allergy to propofol, fentanyl, or ketamine. |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Australia
Study participating centre
Dept Anaesthesia
Clayton
3168
Australia
3168
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 02/04/2005 | Yes | No |
Editorial Notes
07/01/2021: Total final enrolment added.
