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Prevention of Narcotic-Induced Nausea

Primary Purpose

Nausea

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Saline
Phenergan
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea focused on measuring Narcotics, Nausea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Christiana Care Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic

Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.

Outcomes

Primary Outcome Measures

Number of Patients Who Became Nauseated After IV Opiate Administration.

Secondary Outcome Measures

Full Information

First Posted
October 5, 2007
Last Updated
March 12, 2014
Sponsor
Christiana Care Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT00541671
Brief Title
Prevention of Narcotic-Induced Nausea
Official Title
Prevention of Narcotic-induced Nausea With Promethazine, a Randomized, Double-blind Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea
Keywords
Narcotics, Nausea

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
10 c of saline
Intervention Type
Drug
Intervention Name(s)
Phenergan
Intervention Description
Physician ordered dose
Primary Outcome Measure Information:
Title
Number of Patients Who Became Nauseated After IV Opiate Administration.
Time Frame
4 hours post opiate administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient in Christian Care Emergency Department Require intravenous narcotics for painful condition ≥18 years of age Able to visually rate amount of pain and nausea Exclusion Criteria: Hypersensitivity to promethazine or opioids Patient requesting anti-emetic at enrollment Narcotic administration in last 6 hours Pregnancy or currently breast-feeding Known seizure disorder Medical Instability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Perraut, MD
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Prevention of Narcotic-Induced Nausea

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