Intravenous ketamine infusion will result in analgesia
ID
Bron
Verkorte titel
Aandoening
fibromyalgia, pain, analgesic therapy, ketamine
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Pain on visual analogue scale (VAS) <br>
- Ketamine plasma concentration for PK/PK analysis
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Intravenous ketamine infusion will result in analgesia
Onderzoeksopzet
1 intervention day after which a follow-up of 2 months, patients are asked to fill out FIQ weekly.
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Department of Anesthesiology
Albinusdreef 2
M.C.R. Bauer
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262301
fibromyalgia@lumc.nl
Wetenschappers
Department of Anesthesiology
Albinusdreef 2
M.C.R. Bauer
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262301
fibromyalgia@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Fibromyalgia according to the criteria of the American College of Rheumatology;
2. Pain NRS 5 or greater.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1296 |
| NTR-old | NTR1343 |
| Ander register | TREND, Delft (NL); BSIK03016 : LUMC P08.166 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |