Treatment of Pruritus With Intramuscular Promethazine

Phase 4

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride
Promethazine	Promethazine	The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine

Primary Outcome Measures

Name	Time	Method
Does the Addition of Promethazine Reduce Itching After Spinal Morphine for Cesarean Delivery?	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 Outcome Measures

Name	Time	Method
Does Promethazine Impact Level of Consciousness Compared to Placebo After Cesarean Delivery?	Within first 24 hours post cesarean section	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.
Does Promethazine Change Nausea and Vomiting After Cesarean Compared to Normal Saline?	Within first 24 hours post cesarean section	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.