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Treatment of Pruritus With Intramuscular Promethazine

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT04805073
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
19.7
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Stratified randomization design
Primary Purpose:
Treatment
Official Title:
Assessing Efficacy of Intramuscular Promethazine for the Treatment of Intrathecal Morphine Induced Pruritus
Actual Study Start Date :
Aug 9, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Prophylactic intramuscular promethazine does change pruritus in post-partum females that received 100mcg intrathecal morphine [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 Outcome Measures

    1. Promethazine does not change sedation compared to placebo [Within first 24 hours post cesarean section]

      As quantified by the RASS scale with +4 to -5 scale with +4=combative and -5=unrousable

    2. Promethazine does not change pain compared to placebo [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

    3. Promethazine change in nausea and vomiting [Within first 24 hours post cesarean section]

      rated as none, mild, moderate, severe

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UF Health at the University of Florida Gainesville Florida United States 32610

    Sponsors and Collaborators

    • University of Florida

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT04805073
    Other Study ID Numbers:
    • IRB202002297-A
    • OCR40099
    First Posted:
    Mar 18, 2021
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by University of Florida
    cesarean section
    Additional relevant MeSH terms:
    Pruritus
    Promethazine
    Diphenhydramine

    Study Results

    No Results Posted as of Sep 16, 2021