CSF Pharmacokinetics of Ondansetron

Completed · Not applicable

Conditions studied: Pain

In brief

Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron might be an appropriate drug for treating pain after nerve injury (neuropathic pain), by investigating its bio-distribution in the cerebro-spinal fluid, and the genetic variability that may affect that distribution. Study procedures will include iv ondansetron administration, serial blood draws, cerebrospinal fluid (CSF) sampling, pregnancy testing, and possible ECG.

Key facts

Study ID

NCT02901054

Run by

Washington University School of Medicine

People needed

19

Starts

2016-08-25

Expected to finish

2016-11-17

Last updated by the study team

2019-12-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 18 and 70 years old;
• Patients planned to undergo hip or knee arthroplasty with spinal anesthesia;
• Ability to provide informed consent

You may not qualify if…

• Not giving consent to participate in the study;
• Patients with history of or current hepatic or renal insufficiency;
• Patients with BMI ≥ 33;
• Patients with heart failure or active arrhythmias;
• Patients with severe systemic disease that is a constant threat to life;
• Contraindication or allergy to ondansetron;
• Pregnancy or lactation.
• Prisoners

Where it is running

• Washington University in St. Louis — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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