Fibromyalgia ketstudy

Pharmacokinetic-pharmacodynamic modeling of S(+)-ketamine in fibromyalgia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22499

Enrollment

Registered

2008-06-16

Start date

2010-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fibromyalgia, pain, analgesic therapy, ketamine

Interventions

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 a

Eligibility

Inclusion criteria

Inclusion criteria: 1. Fibromyalgia according to the criteria of the American College of Rheumatology; 2. Pain NRS 5 or greater.

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
- Pain on visual analogue scale (VAS) - Ketamine plasma concentration for PK/PK analysis	—

Secondary

Measure	Time frame
- Quality of life improvement (Fibromyalgia impact questionnaire, FIQ)	—

Contacts

Public ContactM.C.R. Bauer

LUMC Department of Anesthesiology Albinusdreef 2

fibromyalgia@lumc.nl+31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)