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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 than naloxone, will allow for increased use of intrathecal narcotics and decrease the use of systemic opioids in the initial post-operative period.
Conditions:
🦠 Pruritus 🦠 Pregnancy Related
🗓️ Study Start (Actual) 9 August 2021
🗓️ Primary Completion (Estimated) 30 June 2024
✅ Study Completion (Estimated) 30 June 2025
👥 Enrollment (Estimated) 110
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Gainesville, Florida, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 99 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 March 2021
  • First Submitted that Met QC Criteria 15 March 2021
  • First Posted 18 March 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 May 2024
  • Last Update Posted 30 May 2024
  • Last Verified May 2024
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