Condition category
Signs and Symptoms
Date applied
10/04/2005
Date assigned
11/04/2005
Last edited
15/12/2006
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 Adam Tucker

ORCID ID

Contact details

Dept Anaesthesia
Monash Medical Centre
246 Clayton Road
Clayton
3168
Australia
+61 3 95946666
adam.tucker@med.monash.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MMC

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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 names

ketamine, propofol, fentanyl

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2005

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Ten healthy male volunteers were recruited via bulletin board advertisements. The volunteers were trained in the test procedures employed and medically screened.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

10

Participant 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.

Recruitment start date

01/01/2005

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Australia

Trial participating centre

Dept Anaesthesia
Clayton
3168
Australia

Sponsor information

Organisation

Monash Medical Centre (Australia)

Sponsor details

246 Clayton Road
Clayton
3168
Australia
+61 3 95946666
adam.tucker@med.monash.edu.au

Sponsor type

Not defined

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Monash Medical Centre

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

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15804361

Publication citations

  1. Tucker AP, Kim YI, Nadeson R, Goodchild CS, 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[ISRCTN83088383]., BMC Anesthesiol, 2005, 5, 1, 2, doi: 10.1186/1471-2253-5-2.

Additional files

Editorial Notes