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Antihistamine

Promethazine for Itching

Phase 4
Recruiting
Led By Jonathan Cates, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pregnant adult female patients of at least 18 years of age consenting to a cesarean birth
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within first 24 hours post cesarean section
Awards & highlights

Study Summary

This trial is testing if promethazine is an effective treatment for ITMIP. If it is, it would allow for increased use of intrathecal narcotics, which would decrease the use of systemic opioids in the initial post-operative period.

Who is the study for?
This trial is for pregnant adult women aged 18 or older who are consenting to a cesarean birth and agree to participate in the study. It's not for men, incarcerated individuals, those with allergies to study medications, conditions preventing spinal anesthesia, prolonged QTc (>500 ms), or any issue making participation unsafe as judged by investigators.Check my eligibility
What is being tested?
The trial tests if Promethazine can effectively treat itching caused by pain control narcotics used during cesarean deliveries. Participants will either receive Promethazine or a placebo to compare outcomes.See study design
What are the potential side effects?
Promethazine may cause drowsiness, dry mouth, blurred vision, constipation and possible allergic reactions. It might also affect certain heart rhythms (QTc prolongation).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a pregnant adult, 18 or older, agreeing to a C-section.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within first 24 hours post cesarean section
This trial's timeline: 3 weeks for screening, Varies for treatment, and within first 24 hours post cesarean section for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prophylactic intramuscular promethazine does change pruritus in post-partum females that received 100mcg intrathecal morphine
Secondary outcome measures
Promethazine change in nausea and vomiting
Promethazine does not change pain compared to placebo
Promethazine does not change sedation compared to placebo

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PromethazineExperimental Treatment1 Intervention
The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine
Group II: PlaceboPlacebo Group1 Intervention
The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Promethazine
FDA approved

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,557 Total Patients Enrolled
Jonathan Cates, MDPrincipal InvestigatorUniversity of Florida

Media Library

Promethazine (Antihistamine) Clinical Trial Eligibility Overview. Trial Name: NCT04805073 — Phase 4
Itching Research Study Groups: Promethazine, Placebo
Itching Clinical Trial 2023: Promethazine Highlights & Side Effects. Trial Name: NCT04805073 — Phase 4
Promethazine (Antihistamine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04805073 — Phase 4

Frequently Asked Questions

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

Has Promethazine obtained official authorization from the FDA?

"The safety of Promethazine has been established through clinical trials, and is thus rated a 3. This drug has already achieved approval in the fourth phase of testing."

Answered by AI

How many research participants are being observed in this investigation?

"Affirmative. Clinicaltrials.gov suggests that this investigation is actively looking for volunteers, having first been posted on August 9th 2021 and last updated September 8th 2021. Significantly, it requires 110 individuals from one location to participate."

Answered by AI

Does the eligibility limit for this study extend beyond 20 years of age?

"This research is open to those aged eighteen or above and ninety-nine or below."

Answered by AI

What afflictions is Promethazine utilized to alleviate?

"Promethazine is an effective form of medication for pain management, alleviating the symptoms associated with vasomotor rhinitis, and providing analgesic relief."

Answered by AI

For whom does this clinical trial present an opportunity?

"This medical trial is currently accepting applicants aged 18-99 who are suffering from pruritus. To be eligible, participants must satisfy additional requirements such as being an expecting mother of at least 18 years old consenting to a cesarean delivery and agreeing to the study's conditions."

Answered by AI

Are there extant research projects which involve Promethazine?

"At present, two trials exploring the efficacy of Promethazine are in progress with none reaching Phase 3. These studies primarily take place at medical centres situated in Gainesville, Florida; however, other sites across the USA have also opened investigations into this drug."

Answered by AI

Are there any unfilled openings yet for those wishing to participate in this experimentation?

"Affirmative. According to the information available on clinicaltrials.gov, this medical research is still seeking participants and was first uploaded on August 9th 2021 with a subsequent edit made September 8th 2021. 110 individuals are required from 1 site for completion of the project."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Treatment of Pruritus With Intramuscular Promethazine
2021. "Treatment of Pruritus With Intramuscular Promethazine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04805073.
~6 spots leftby Jun 2024
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