Prevention of Narcotic-Induced Nausea
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|ClinicalTrials.gov Identifier: NCT00541671|
Recruitment Status : Terminated (Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated)
First Posted : October 10, 2007
Results First Posted : March 13, 2014
Last Update Posted : March 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Nausea||Drug: Saline Drug: Phenergan||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Prevention of Narcotic-induced Nausea With Promethazine, a Randomized, Double-blind Placebo-controlled Trial|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||November 2009|
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
- Number of Patients Who Became Nauseated After IV Opiate Administration. [ Time Frame: 4 hours post opiate administration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541671
|United States, Delaware|
|Christiana Care Health Services|
|Newark, Delaware, United States, 19718|
|Principal Investigator:||Michael Perraut, MD||Christiana Care Health Services|