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Treatment Group 1. Pre-Intrathecal 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Nausea PACU

Nausea Post PACU

Pruritus parameters PACU

+4 more

Secondary outcome measures

Post-operative Pain

Other outcome measures

Blood pressure Mother

Blood pressure- Infant

ECG Infant

+5 more

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

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Wayne State UniversityLead Sponsor

307 Previous Clinical Trials

108,407 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to take part in this clinical trial?

"Individuals aged between 18 and 50 experiencing drug-induced pruritus are eligible for inclusion in this research. Approximately 66 participants will be admitted to the trial."

Answered by AI

Is the clinical trial open to individuals younger than 45 years old?

"Individuals aged between 18 and 50 are eligible for participation in this clinical trial. It is worth noting that there is one study designated for those below 18 years of age, while seventeen studies cater to individuals over the age of 65."

Answered by AI

Is the treatment protocol for Group 1 before intrathecal administration FDA-approved?

"According to our team at Power, the safety rating for Treatment Group 1. Pre-Intrathecal is a score of 1 due to being in an early Phase 1 trial with scarce data backing its safety and efficacy."

Answered by AI

Are there any available positions for participants in this research study?

"According to information available on clinicaltrials.gov, recruitment for this trial has concluded. The original posting date was March 1st, 2024, with the most recent update made on March 5th, 2024. While this specific trial is no longer accepting participants, it's worth noting that there are currently 24 other trials actively seeking candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ondansetron Use for Preventing Pruritus In Patients Undergoing Cesarean Section

Justin Hruska 2024. "Ondansetron Use for Preventing Pruritus In Patients Undergoing Cesarean Section". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06297499.