Treatment of Pruritus With Intramuscular Promethazine

Assessing Efficacy of Intramuscular Promethazine for the Treatment of Intrathecal Morphine Induced Pruritus

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Pruritus
• Intervention / Treatment: Drug: Promethazine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amy Gunnett; Phone Number: 352-273-8911; Email: AGunnett@anest.ufl.edu
• Study Contact Backup: Name: Regina Knudsen; Phone Number: 352-273-6786; Email: rknudsen@anest.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • UF Health at the University of Florida
      • Contact: Amy Gunnett; Phone Number: 352-273-8911; Email: AGunnett@anest.ufl.edu
      • Principal Investigator: Jonathan Cates, MD
      • Sub-Investigator: Adam Wendling, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Promethazine; The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine	Drug: Promethazine; 1cc 25mg/ml Promethazine (study medication); Other Names: Phenergan
Placebo Comparator: Placebo; The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride	Drug: Placebo; 1cc 0.9% Sodium Chloride (placebo); Other Names: salt water

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Promethazine does not change sedation compared to placebo	As quantified by the RASS scale with +4 to -5 scale with +4=combative and -5=unrousable	Within first 24 hours post cesarean section
Promethazine does not change pain compared to placebo	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	Within first 24 hours post cesarean section
Promethazine change in nausea and vomiting	rated as none, mild, moderate, severe	Within first 24 hours post cesarean section

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Jonathan Cates, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: cesarean section
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Hypnotics and Sedatives; Anesthetics, Local; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Diphenhydramine; Promethazine
• Other Study ID Numbers: IRB202002297-A; OCR40099 (Other Identifier: UFOnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes