CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 72 enrolled
Drug / intervention
Promethazine +1 moredrug
Likely dose
Promethazine 25mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04805073
NCT04805073Phase 4Completed
CompareCT.gov

Assessing Efficacy of Intramuscular Promethazine for the Treatment of Intrathecal Morphine Induced Pruritus

University of Florida·interventional·Posted Mar 18, 2021·Updated May 4, 2025

In Brief

A Phase 4 clinical trial evaluating Promethazine and Placebo for Pruritus and Pregnancy Related. Completed, enrolled 72 participants across 1 site.

Detailed Summary

Neuraxial narcotics are commonly used in obstetric patients for cesarean delivery to help with pain control over the first 24 hours after the surgery. The aim is to evaluate effectiveness of promethazine (IMP) treatment of intrathecal morphine induced pruritus (ITIMIP). A treatment for ITMIP, other than naloxone, will allow for increased use of intrathecal narcotics and decrease the use of systemic opioids in the initial post-operative period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPruritus, Pregnancy Related
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMar 18, 2021
Enrollment StartAug 9, 2021
Primary CompletionMay 30, 2024
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 5.3 years ago

Interventions

Promethazinedrug

1cc 25mg/ml Promethazine (study medication)

Placebodrug

1cc 0.9% Sodium Chloride (placebo)