Treatment of Pruritus With Intramuscular Promethazine

Study Overview
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Brief Summary
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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.

Official Title
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Assessing Efficacy of Intramuscular Promethazine for the Treatment of Intrathecal Morphine Induced Pruritus

Conditions
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Pruritus, Pregnancy Related

Intervention / Treatment
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* Drug: Promethazine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Promethazine<br>The treatment will consist of a blinded syringe of 1cc clear liquid 25mg/ml Promethazine | Drug: Promethazine<br>* 1cc 25mg/ml Promethazine (study medication)<br>* Other names: Phenergan;|
| Placebo Comparator: Placebo<br>The treatment will consist of a blinded syringe of 1cc 0.9% Sodium Chloride | Drug: Placebo<br>* 1cc 0.9% Sodium Chloride (placebo)<br>* Other names: salt water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prophylactic intramuscular promethazine does change pruritus in post-partum females that received 100mcg intrathecal morphine | Pruritus will be quantified by the ItchyQuant Scale with 0 -10 scale with 0=no itch and 10-the worst itch | Within first 24 hours post cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Promethazine does not change sedation compared to placebo | As quantified by the RASS scale with +4 to -5 scale with +4=combative and -5=unrousable | Within first 24 hours post cesarean section | 
| Promethazine does not change pain compared to placebo | As quantified by the DVPRS scale with 0-10 scale with 0=no pain and 10=as bad as it could be, nothing else matters | Within first 24 hours post cesarean section | 
| Promethazine change in nausea and vomiting | rated as none, mild, moderate, severe | Within first 24 hours post cesarean section | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section