To test the hypothesis that ketamine has a modulatory effect on fibromyalgia
ID
Source
Brief title
Condition
- General system disorders NEC
- Muscle disorders
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
painscores on a visual analogue scale (VAS)
quality of life: fibromyalgia impact questionnaire (FIQ)
Secondary outcome
Furthermore this study investigate the pharmacokinetics and pharmacodynamics of
(S+)-ketamine in subanaesthetic doses in fybromyalgia.
Background summary
The treatment of Complex Regional Pain Syndrome type 1 (CRPS) with S(+)
ketamine showed good pain relief for weeks. Experimental pain responses
returned to baseline almost immediately after the end of ketamine infusion.
This suggests that ketamine might have modulatory effect on chronic pain in
general.
Study objective
To test the hypothesis that ketamine has a modulatory effect on fibromyalgia
Study design
open treatment for two hours, total study duration five hours
Intervention
ketamine infusion
Study burden and risks
mild temporarily occurrence of side effects such as vivid dreams, high feeling,
and nausea.
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
fibromyalgia patients
Exclusion criteria
Obesity (BMI > 30);
Presence of psychiatric disease;
History of chronic alcohol or drug use;
Known allergy to study medications;
Possibility of pregnancy; and
Lactation.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-004002-14-NL |
| CCMO | NL23851.058.08 |