Treatment of Pruritus With Intramuscular Promethazine

University of Florida

Status and phase: Completed; Phase 4

Conditions: Pregnancy Related; Pruritus

Treatments: Drug: Placebo; Drug: Promethazine

Study type: Interventional

Funder types: Other

Identifiers

NCT04805073

IRB202002297-A

OCR40099 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups, including a placebo group

Promethazine

Experimental group

Description:

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

Treatment:

Drug: Promethazine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo