N/A
N=19
CSF Pharmacokinetics of Ondansetron
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02901054 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: CSF to Plasma Concentration Ratio — 0.15 Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ondansetron (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CSF to Plasma Concentration Ratio |
0.15 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age between 18 and 70 years old;
- Patients planned to undergo hip or knee arthroplasty with spinal anesthesia;
- Ability to provide informed consent
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02901054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.