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Prevention of Narcotic-Induced Nausea

This study has been completed.
Sponsor:
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00541671
First received: October 5, 2007
Last updated: July 13, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention
Nausea
 Drug: Saline
Drug: Phenergan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Prevention of Narcotic-induced Nausea With Promethazine, a Randomized, Double-blind Placebo-controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 164
Study Start Date: February 2007
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541671

Locations
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: Michael Perraut, MD Christiana Care Health Services
  More Information

No publications provided

Responsible Party: Melissa Bollinger, Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00541671     History of Changes
Other Study ID Numbers: 27002
Study First Received: October 5, 2007
Last Updated: July 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Narcotics
Nausea

Additional relevant MeSH terms:
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Promethazine
Narcotics
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
 Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013