Prevention of Narcotic-Induced Nausea

Study Overview
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Brief Summary
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We are doing this study to find out if extra medicine is needed to avoid the chance of nausea sometimes linked to narcotic pain medicine (for example, morphine, dilaudid, fentanyl). Some doctors always give medicine to prevent the possible side effect of nausea, while others do not. We are looking to see if this extra medicine is helpful in preventing nausea. The goal is to screen all patients with pain and enroll enough subjects to reach our goal of 164 evaluable study participants.

Detailed Description
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Patients will be randomized to one of two study groups. They will then be asked to rate their pain and nausea on a line graph. If the patient is a female of child bearing age, a urine pregnancy test will be done per standard of care. After this, an IV catheter will be placed in a vein in the patients arm. Pain medicine will be given through this IV per the doctor's order. With this medicine, patients will be given 10 milliliters (2 teaspoons) of either Sodium Chloride (salt water) or Phenergan mixed with Sodium Chloride (salt water). Phenergan is a medication typically used to help with nausea and is a common ingredient in prescription cough medicine. After this is finished, patients will be asked to rate their pain and nausea in 30 minutes, and again 1, 2, and 4 hours later. If the doctor decides the patient is able to be discharged from the emergency room before the 4 hours are up, they will be asked to rate your pain and nausea again before going home, and the study will be stopped at that time.

Official Title
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Prevention of Narcotic-induced Nausea With Promethazine, a Randomized, Double-blind Placebo-controlled Trial

Conditions
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Nausea

Intervention / Treatment
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* Drug: Saline
* Drug: Phenergan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient in Christian Care Emergency Department Require intravenous narcotics for painful condition ≥18 years of age Able to visually rate amount of pain and nausea Exclusion Criteria: Hypersensitivity to promethazine or opioids Patient requesting anti-emetic at enrollment Narcotic administration in last 6 hours Pregnancy or currently breast-feeding Known seizure disorder Medical Instability

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic | Drug: Saline<br>* 10 c of saline<br>|
| Active Comparator: 2<br>Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline. | Drug: Phenergan<br>* Physician ordered dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Became Nauseated After IV Opiate Administration. |  | 4 hours post opiate administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Narcotics, Nausea