Clinical Trials Directory

Trials / Completed

CompletedNCT04805073

Treatment of Pruritus With Intramuscular Promethazine

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
72 (actual)
Sponsor
University of Florida · Academic / Other
Sex
Female
Age
18 Years – 99 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGPromethazine1cc 25mg/ml Promethazine (study medication)
DRUGPlacebo1cc 0.9% Sodium Chloride (placebo)

Timeline

Start date
2021-08-09
Primary completion
2024-05-30
Completion
2024-05-30
First posted
2021-03-18
Last updated
2025-05-04
Results posted
2025-05-04

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04805073. Inclusion in this directory is not an endorsement.