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Treatment of Pruritus With Intramuscular Promethazine

Primary Purpose

Pruritus, Pregnancy Related

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Promethazine
Placebo
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus focused on measuring cesarean section

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • UF Health at the University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Promethazine

Placebo

Arm Description

The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine

The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Promethazine change in nausea and vomiting
rated as none, mild, moderate, severe

Full Information

First Posted
March 15, 2021
Last Updated
May 25, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT04805073
Brief Title
Treatment of Pruritus With Intramuscular Promethazine
Official Title
Assessing Efficacy of Intramuscular Promethazine for the Treatment of Intrathecal Morphine Induced Pruritus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Pregnancy Related
Keywords
cesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Stratified randomization design
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Promethazine
Arm Type
Experimental
Arm Description
The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride
Intervention Type
Drug
Intervention Name(s)
Promethazine
Other Intervention Name(s)
Phenergan
Intervention Description
1cc 25mg/ml Promethazine (study medication)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
salt water
Intervention Description
1cc 0.9% Sodium Chloride (placebo)
Primary Outcome Measure Information:
Title
Prophylactic intramuscular promethazine does change pruritus in post-partum females that received 100mcg intrathecal morphine
Description
Pruritus will be quantified by the ItchyQuant Scale with 0 -10 scale with 0=no itch and 10-the worst itch
Time Frame
Within first 24 hours post cesarean section
Secondary Outcome Measure Information:
Title
Promethazine does not change sedation compared to placebo
Description
As quantified by the RASS scale with +4 to -5 scale with +4=combative and -5=unrousable
Time Frame
Within first 24 hours post cesarean section
Title
Promethazine does not change pain compared to placebo
Description
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
Time Frame
Within first 24 hours post cesarean section
Title
Promethazine change in nausea and vomiting
Description
rated as none, mild, moderate, severe
Time Frame
Within first 24 hours post cesarean section

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant adult female patients of at least 18 years of age consenting to a cesarean birth.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Regina Knudsen
Phone
352-273-6786
Email
rknudsen@anest.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Gunnett
Phone
352-273-8911
Email
AGunnett@anest.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Cates, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Gunnett
Phone
352-273-8911
Email
AGunnett@anest.ufl.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Cates, MD
First Name & Middle Initial & Last Name & Degree
Adam Wendling, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment of Pruritus With Intramuscular Promethazine

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