← Back to Search

Ondansetron for Drug-Induced Itching

Phase 1

Waitlist Available

Research Sponsored by Wayne State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up taken while patient in pacu at 0 minutes, 15 minutes, 30 minutes, 45 minutes and 60 min. post pacu patient assessment at at 8 hours, 16 hours, 24 hours post-operative period

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the use of ondansetron, a common anti-nausea medication, in reducing itching and nausea caused by spinal opioids given during cesarean deliveries. The study

Who is the study for?

This trial is for pregnant women undergoing cesarean section who experience itching due to spinal opioids used in anesthesia. Participants should not have any conditions that would make using Ondansetron unsafe.

What is being tested?

The study tests if giving Ondansetron (8mg) at different times can reduce itching or nausea and vomiting caused by opioids added to local anesthetics during cesarean sections. It's a prospective study, meaning it observes outcomes over time.

What are the potential side effects?

Ondansetron may cause headaches, constipation, fatigue, or a warm or red face called flushing. Rarely, it might affect heart rhythm or cause severe allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ taken while patient in pacu at 0 minutes, 15 minutes, 30 minutes, 45 minutes and 60 min. post pacu patient assessment at at 8 hours, 16 hours, 24 hours post-operative period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~taken while patient in pacu at 0 minutes, 15 minutes, 30 minutes, 45 minutes and 60 min. post pacu patient assessment at at 8 hours, 16 hours, 24 hours post-operative period

This trial's timeline: 3 weeks for screening, Varies for treatment, and taken while patient in pacu at 0 minutes, 15 minutes, 30 minutes, 45 minutes and 60 min. post pacu patient assessment at at 8 hours, 16 hours, 24 hours post-operative period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Nausea PACU

Nausea Post PACU

Pruritus parameters PACU

+4 more

Secondary study objectives

Post-operative Pain

Other study objectives

Blood pressure Mother

Blood pressure- Infant

ECG Infant

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Group 1. Pre-IntrathecalExperimental Treatment1 Intervention

Patients will receive an IV solution of 8mg ondansetron (4ml) within 30 minutes of the standard-of-care anesthetic treatment (intrathecal morphine administration) followed by a placebo treatment of an IV solution of 4ml 0.9% saline administered at the time of umbilical cord clamping.

Group II: Treatment Group 2 Cord clampingActive Control1 Intervention

Patients will receive a placebo treatment of an IV solution of 4ml 0.9% saline administered within 30 minutes of the standard-of-care anesthetic treatment (intrathecal morphine administration) followed by an IV solution of 8mg ondansetron (4ml) administered at the time of umbilical cord clamping.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ondansetron 8mg

2022

Completed Phase 4

~450

Do I qualify?Apply below to find out