Treatment of Pruritus With Intramuscular Promethazine

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Florida
• Treatments: Diphenhydramine; Promethazine

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.