Prevention of Narcotic-Induced Nausea

NCT00541671 | Terminated Results

• 1 other identifier: 27002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea

Keywords

Narcotics; Nausea

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Became Nauseated After IV Opiate Administration.

  4 hours post opiate administration

Study Arms (2)

1

PLACEBO COMPARATOR

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

Drug: Saline

2

ACTIVE COMPARATOR

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

Drug: Phenergan

Interventions

Saline DRUG

10 c of saline

1

Phenergan DRUG

Physician ordered dose

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Nausea

Interventions

Sodium Chloride; Promethazine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Propylamines; Amines; Organic Chemicals; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination due to small numbers of subjects and incomplete data for analysis

Results Point of Contact

• Title: Deb Marco
• Organization: Christiana Care Health System

DMarco@christianacare.org

302-733-4130

Study Officials

• Michael Perraut, MD

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 10, 2007
• Study Start: February 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 13, 2014
• Results First Posted: March 13, 2014

Record last verified: 2014-03

Locations

US (1)