Treatment of Pruritus With Intramuscular Promethazine

Overview

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.

Full Title of Study: “Assessing Efficacy of Intramuscular Promethazine for the Treatment of Intrathecal Morphine Induced Pruritus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: April 2023

Interventions

  • Drug: Promethazine
    • 1cc 25mg/ml Promethazine (study medication)
  • Drug: Placebo
    • 1cc 0.9% Sodium Chloride (placebo)

Arms, Groups and Cohorts

  • Experimental: Promethazine
    • The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine
  • Placebo Comparator: Placebo
    • The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride

Clinical Trial Outcome Measures

Primary Measures

  • Prophylactic intramuscular promethazine does change pruritus in post-partum females that received 100mcg intrathecal morphine
    • Time Frame: Within first 24 hours post cesarean section
    • Pruritus will be quantified by the ItchyQuant Scale with 0 -10 scale with 0=no itch and 10-the worst itch

Secondary Measures

  • Promethazine does not change sedation compared to placebo
    • Time Frame: Within first 24 hours post cesarean section
    • As quantified by the RASS scale with +4 to -5 scale with +4=combative and -5=unrousable
  • Promethazine does not change pain compared to placebo
    • Time Frame: Within first 24 hours post cesarean section
    • As quantified by the DVPRS scale with 0-10 scale with 0=no pain and 10=as bad as it could be, nothing else matters
  • Promethazine change in nausea and vomiting
    • Time Frame: Within first 24 hours post cesarean section
    • rated as none, mild, moderate, severe

Participating in This Clinical Trial

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.

Gender Eligibility: Female

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

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Florida
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jonathan Cates, MD, Principal Investigator, University of Florida
  • Overall Contact(s)
    • Sara Harris, 352-273-6786, SCroft@anest.ufl.edu

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