Treatment of Pruritus With Intramuscular Promethazine

University of Florida72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pruritus Pregnancy Related

Interventions

PromethazineDRUG

1cc 25mg/ml Promethazine (study medication)

PlaceboDRUG

1cc 0.9% Sodium Chloride (placebo)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

UF Health at the University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery?

Pruritus (itching) will be quantified by the ItchyQuant Scale. The ItchyQuant scale is a 0 -10 scale with 0 denoting no itch and 10, the worst itch possible. Participants were asked at 3 different time points (1 hour, 4 hours and 24 hours) after surgery to rate their itching. In the results here we reported any itching (a score greater than zero on the ItchyQuant scale) at 24 hours after surgery in each group.

Time frame: Within first 24 hours after cesarean section

Secondary Outcomes

Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery?

Level of consciousness will be quantified by the RASS Scale. The RASS scale is scored with +4 to -5 scale with +4=combative, 0=alert and calm and -5=unrousable. Participants were asked at 3 different time points (1 hour, 4 hours and 24 hours) after surgery to rate their level of consciousness. In the results here we reported any score not noted to be 0 (alert and calm) at 24 hours after surgery in each group.

Time frame: Within first 24 hours post cesarean section

Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline?

We asked patients to rate their sensation of nausea and/or vomiting as none, mild, moderate or severe at 4 time points after cesarean (1 hour, 4 hours and 24 hours after cesarean). Here, we rate any report of nausea and/or vomiting as opposed to no nausea and/or vomiting at 24 hours after cesarean among the patients who had Promethazine and normal saline.

Time frame: Within first 24 hours post cesarean section

Data from ClinicalTrials.gov

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