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NCT06297499 · ClinicalTrials.gov registry record · Phase 1
Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section
A Phase 1 study of Pruritus Caused by Drug, sponsored by Wayne State University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT06297499: Recruiting Phase 1 study of Pruritus Caused by Drug, sponsored by Wayne State University.
NCT06297499 is a Phase 1 study of Pruritus Caused by Drug that is actively recruiting participants, run by Wayne State University. The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06297499, a Phase 1 study of Pruritus Caused by Drug, is actively recruiting participants, sponsored by Wayne State University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration.
Primary Outcome
Patient Assessment (patient questionnaire): Pruritus occurrence (Yes or no) and anatomical location of Pruritus of occurrence, Severity of Pruritus- Likert scale choices from (Not present, Mild, Moderate, Severe, Unbearable) severity
Conditions Studied
Interventions
- DRUG Ondansetron 8mg
Study Locations (1)
Michigan
- Detroit Medical Center- Hutzel Women's Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2024-08-22 |
| Est. Completion | 2025-12-01 |
| Phase | Phase 1 |
What NCT06297499 shows while recruiting
NCT06297499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).
The record links to 1 condition, with Pruritus Caused by Drug appearing as the primary indexed condition, and to 1 intervention - of which Ondansetron 8mg is the first listed.
NCT06297499 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06297499 about?
NCT06297499 is a clinical study titled "Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section". Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can v...
What is the current status of trial NCT06297499?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2024-08-22. Estimated completion is 2025-12-01.
What conditions does trial NCT06297499 study?
This clinical trial studies the following conditions: Pruritus Caused by Drug.
What interventions are being tested in trial NCT06297499?
The interventions under investigation include: Ondansetron 8mg (DRUG).
Who is sponsoring clinical trial NCT06297499?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06297499 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06297499's enrollment target sits among peer trials
66 786th of 2000 higher than 1,203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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