- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00541671
Prevention of Narcotic-Induced Nausea
Prevention of Narcotic-induced Nausea With Promethazine, a Randomized, Double-blind Placebo-controlled Trial
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19718
- Christiana Care Health Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
|
10 c of saline
|
Active Comparator: 2
Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
|
Physician ordered dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Patients Who Became Nauseated After IV Opiate Administration.
Time Frame: 4 hours post opiate administration
|
4 hours post opiate administration
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Perraut, MD, Christiana Care Health Services
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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