Clinical TrialEsketaminePlaceboCompleted

Pharmacokinetic-Pharmacodynamic Modeling of S(+)-Ketamine in Fibromyalgia: A Randomized, Double-Blind, Active Placebo-Controlled Trial

Randomized double-blind active placebo-controlled trial (LUMC Department of Anesthesiology, Leiden, Netherlands) of a single 30-minute IV infusion of S(+)-ketamine 0.5 mg/kg vs midazolam 5 mg (active placebo) in adult fibromyalgia patients (ACR 1990 criteria, baseline spontaneous pain VAS ≥5). Target enrollment: 24 (12 per arm). Primary outcomes: spontaneous fibromyalgia pain (VAS, acute phase at 45–180 min) and plasma S-ketamine/S-norketamine concentrations for PKPD modeling. Secondary outcomes: Fibromyalgia Impact Questionnaire (FIQ) and experimental heat pain (thermode VAS), both assessed weekly over 8 weeks of follow-up. Additional registry IDs: NL1296 (new NTR), NL23851.058.08 (CCMO), NL-OMON 22499. Supported by TREND Delft.

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Target Enrollment
24 participants
Study Type
interventional
Design
Randomized, double Blind

Study Arms & Interventions

S-ketamine

experimental

30-min intravenous infusion of S-ketamine

Interventions

  • Esketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    30-min infusion

Midazolam

placebo

30-min intravenous infusion of midazolam (active placebo)

Interventions

  • Placebo5 mg
    via IV• single dose• 1 doses total

    30-min infusion; used as an active placebo to control for sedation and side effects

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2010-02-01
    End: 2011-04-01
  • Compounds
    EsketaminePlacebo

Related Publications

Open AccessindividualPrimary

Absence of long-term analgesic effect from a short-term S-ketamine infusion on fibromyalgia pain: A randomized, prospective, double blind, active placebo-controlled trial

In a randomised, double-blind, active placebo-controlled trial of 24 fibromyalgia patients, a 30‑minute S‑ketamine infusion produced transient pain reductions that closely tracked plasma levels but yielded no significant long-term analgesic benefit over an eight‑week follow‑up versus midazolam. Side effects were mild–moderate and declined rapidly, suggesting adequate blinding.

Published
Journal
European Journal of Pain
Authors
Noppers, I., Niesters, M., Swartjes, M., Bauer, M., Aarts, L., Geleijnse, N., Mooren, R., Dahanl, A., Sarton, E.