Status:

COMPLETED

Treatment of Pruritus With Intramuscular Promethazine

Lead Sponsor:

University of Florida

Conditions:

Pruritus

Pregnancy Related

Eligibility:

FEMALE

18-99 years

Phase:

PHASE4

Brief 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 promethaz...

Eligibility Criteria

Inclusion

  • Pregnant adult female patients of at least 18 years of age consenting to a cesarean birth
  • Willing to consent to study.

Exclusion

  • 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.

Key Trial Info

Start Date :

August 9 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 30 2024

Estimated Enrollment :

72 Patients enrolled

Trial Details

Trial ID

NCT04805073

Start Date

August 9 2021

End Date

May 30 2024

Last Update

May 4 2025

Active Locations (1)

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1

UF Health at the University of Florida

Gainesville, Florida, United States, 32610