Treatment of Pruritus With Intramuscular Promethazine

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04805073
• Other study ID #: IRB202002297-A
• Secondary ID: OCR40099
• Status: Recruiting
• Phase: Phase 4
• Start date: August 9, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: Brandi Lattinville
• Phone: 352-294-8346
• Email: blattinville[@]anest.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Related
• Pruritus

Intervention

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

Locations

Country	Name	City	State
United States	UF Health at the University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Promethazine change in nausea and vomiting	rated as none, mild, moderate, severe	Within first 24 hours post cesarean section