Prevention of Narcotic-Induced Nausea
Information source: Christiana Care Health Services
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea
Intervention: Saline (Drug); Phenergan (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Christiana Care Health Services Official(s) and/or principal investigator(s):
Michael Perraut, MD, Principal Investigator, Affiliation: Christiana Care Health Services
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.
Clinical Details
Official title: Prevention of Narcotic-induced Nausea With Promethazine, a Randomized, Double-blind Placebo-controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Primary outcome: Number of Patients Who Became Nauseated After IV Opiate Administration.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patient in Christian Care Emergency Department
2. Require intravenous narcotics for painful condition
3. ≥18 years of age
4. Able to visually rate amount of pain and nausea
Exclusion Criteria:
1. Hypersensitivity to promethazine or opioids
2. Patient requesting anti-emetic at enrollment
3. Narcotic administration in last 6 hours
4. Pregnancy or currently breast-feeding
5. Known seizure disorder
6. Medical Instability
Locations and Contacts
Christiana Care Health Services, Newark, Delaware 19718, United States
Additional Information
Starting date: February 2007
Last updated: March 12, 2014
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