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NCT04805073 · ClinicalTrials.gov registry record · Phase 4
Treatment of Pruritus With Intramuscular Promethazine
A Phase 4 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
NCT04805073: Completed Phase 4 study, sponsored by University of Florida.
NCT04805073 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 72 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04805073, a Phase 4 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
Study 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.
Primary Outcome
Pruritus (itching) will be quantified by the ItchyQuant Scale. The ItchyQuant scale is a 0 -10 scale with 0 denoting no itch and 10, the worst itch possible. Participants were asked at 3 different time points (1 hour, 4 hours and 24 hours) after surgery to rate their itching. In the results here we reported any itching (a score greater than zero on the ItchyQuant scale) at 24 hours after surgery in each group.
Interventions
- DRUG Placebo
- DRUG Promethazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2021-08-09 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 4 |
What the finished NCT04805073 record still lists
NCT04805073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04805073 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04805073 about?
NCT04805073 is a clinical study titled "Treatment of Pruritus With Intramuscular Promethazine". 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 ...
What is the current status of trial NCT04805073?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2021-08-09. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT04805073?
The interventions under investigation include: Placebo (DRUG), Promethazine (DRUG).
Who is sponsoring clinical trial NCT04805073?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04805073's enrollment target sits among peer trials
72 1035th of 2000 higher than 961 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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