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Fibromyalgia ketstudy


- candidate number3476
- NTR NumberNTR1343
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-jun-2008
- Secondary IDsLUMC P08.166 TREND, Delft (NL); BSIK03016
- Public TitleFibromyalgia ketstudy
- Scientific TitlePharmacokinetic-pharmacodynamic modeling of S(+)-ketamine in fibromyalgia
- ACRONYMN/A
- hypothesisIntravenous ketamine infusion will result in analgesia
- Healt Condition(s) or Problem(s) studiedFibromyalgia, Pain, Ketamine , Analgesic therapy
- Inclusion criteria1. Fibromyalgia according to the criteria of the American College of Rheumatology;
2. Pain NRS 5 or greater.
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2010
- planned closingdate1-jul-2010
- Target number of participants24
- InterventionsPatients 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.
- 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)
- Timepoints1 intervention day after which a follow-up of 2 months, patients are asked to fill out FIQ weekly.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.C.R. Bauer
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Albert Dahan
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Anaesthesiology
- Funding
(Source(s) of Monetary or Material Support)
TREND Delft
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD16-jun-2008 - 28-jan-2010


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