Clinical Trial: Prevention of Narcotic-Induced Nausea
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Prevention of Narcotic-induced Nausea With Promethazine, a Randomized, Double-blind Placebo-controlled Trial
Brief Summary: 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 Summary:
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.
Sponsor: Christiana Care Health Services
Current Primary Outcome: Number of Patients Who Became Nauseated After IV Opiate Administration. [ Time Frame: 4 hours post opiate administration ]
Original Primary Outcome: Number of episodes of forceful production of vomit or retching occurring more than 5 minutes apart, individually will be collected [ Time Frame: up to 4hrs ]
Current Secondary Outcome:
Original Secondary Outcome: Determine the rate of adverse reactions with promethazine co-administration compared to placebo, and, if statistically significant, the number needed to harm. [ Time Frame: up to 4 hours ]
Information By: Christiana Care Health Services
Dates:
Date Received: October 5, 2007
Date Started: February 2007
Date Completion:
Last Updated: March 12, 2014
Last Verified: March 2014
