No registrations found.
ID
Source
Brief title
Health condition
fibromyalgia, pain, analgesic therapy, ketamine
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Pain on visual analogue scale (VAS)
- Ketamine plasma concentration for PK/PK analysis
Secondary outcome
- Quality of life improvement (Fibromyalgia impact questionnaire, FIQ)
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. To test this hypothesis this study is designed to study its efficacy in fibromyalgia patients on pain appreciation. Furthermore this study investigate the pharmacokinetics and pharmacodynamics of (S+)-ketamine in subanaesthetic doses in fybromyalgia.
Study objective
Intravenous ketamine infusion will result in analgesia
Study design
1 intervention day after which a follow-up of 2 months, patients are asked to fill out FIQ weekly.
Intervention
Patients receive an intravenous infusion of S(+)-ketamine (0,5 mg/kg) of midazolam (5 mg) over 30 minutes in a randomised double blind fashion. Follow-up on the intervention day is 2,5 hours. During and after infusion blood samples will be drawn for PK/PD analysis. After infusion fibromyalgia pain scores, heat pain scores and scores for side effects will be obtained. After the intervention day patients will be monitored with a questionnaire.
Department of Anesthesiology
Albinusdreef 2
M.C.R. Bauer
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262301
fibromyalgia@lumc.nl
Department of Anesthesiology
Albinusdreef 2
M.C.R. Bauer
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262301
fibromyalgia@lumc.nl
Inclusion criteria
1. Fibromyalgia according to the criteria of the American College of Rheumatology;
2. Pain NRS 5 or greater.
Exclusion criteria
1. Obesity (BMI > 30);
2. Presence of psychiatric disease;
3. History of chronic alcohol or drug use;
4. Known allergy to study medications;
5. Possibility of pregnancy;
6. Lactation
Design
Recruitment
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 |
|---|---|
| NTR-new | NL1296 |
| NTR-old | NTR1343 |
| Other | TREND, Delft (NL); BSIK03016 : LUMC P08.166 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |