Clinical trial NCT04805073: Treatment of Pruritus With Intramuscular Promethazine
Official title: Assessing Efficacy of Intramuscular Promethazine for the Treatment of Intrathecal Morphine Induced Pruritus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pruritus
Pregnancy Related
Keywords: cesarean section
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery?
timeFrame: Within first 24 hours after cesarean section
Secondary outcomes:
measure: Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery?
timeFrame: Within first 24 hours post cesarean section
measure: Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline?
timeFrame: Within first 24 hours post cesarean section
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Adam Wendling, MD
role: PRINCIPAL_INVESTIGATOR
References:
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