COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Prevention of Narcotic-Induced Nausea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Christiana Care Health Services

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.

Condition or disease Intervention/treatment Phase
Nausea Drug: Saline Drug: Phenergan Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
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

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
Drug: Saline
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.
Drug: Phenergan
Physician ordered dose

Primary Outcome Measures :
  1. Number of Patients Who Became Nauseated After IV Opiate Administration. [ Time Frame: 4 hours post opiate administration ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00541671

Layout table for location information
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Layout table for investigator information
Principal Investigator: Michael Perraut, MD Christiana Care Health Services
Layout table for additonal information
Responsible Party: Christiana Care Health Services Identifier: NCT00541671    
Other Study ID Numbers: 27002
First Posted: October 10, 2007    Key Record Dates
Results First Posted: March 13, 2014
Last Update Posted: March 13, 2014
Last Verified: March 2014
Keywords provided by Christiana Care Health Services:
Additional relevant MeSH terms:
Layout table for MeSH terms
Signs and Symptoms, Digestive
Signs and Symptoms
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents