Phase 4
N=72
Treatment of Pruritus With Intramuscular Promethazine
Pruritus · Pregnancy Related
Bottom Line
View on ClinicalTrials.gov: NCT04805073 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery? — 22; 17; 10; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Promethazine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Florida
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery? |
22; 17; 10; 15 | — |
| SECONDARY Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery? |
32; 31; 0; 1 | — |
| SECONDARY Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline? |
31; 32; 1; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Pregnant adult female patients of at least 18 years of age consenting to a cesarean birth
- Willing to consent to study.
Exclusion Criteria
- Male patients
- Incarceration
- Inability to communicate with the investigators
- Allergies to any medications used in the study
- Possessing any contraindication to spinal anesthesia (lack of consent, elevated intracranial pressure, preexisting neurological disease, thrombocytopenia/coagulopathy, hypovolemia, infection at the site of the procedure)
- Patients with an already prolonged QTc (>500 ms)
- Any reason an investigator believes study participation would not be in the best interest of the potential subject.
Data sourced from ClinicalTrials.gov (NCT04805073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.