Assessing Efficacy of Intramuscular Promethazine for the Treatment of Intrathecal Morphine Induced Pruritus
Overview
- Phase
- Phase 4
- Intervention
- Promethazine
- Conditions
- Pruritus
- Sponsor
- University of Florida
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery?
- Status
- Completed
- Last Updated
- 12 months ago
Overview
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.
Investigators
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.
Arms & Interventions
Promethazine
The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine
Intervention: Promethazine
Placebo
The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride
Intervention: Placebo
Outcomes
Primary Outcomes
Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery?
Time Frame: Within first 24 hours after cesarean section
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.
Secondary Outcomes
- Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery?(Within first 24 hours post cesarean section)
- Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline?(Within first 24 hours post cesarean section)