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Prevention of Narcotic-Induced Nausea

Information source: Christiana Care Health Services
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nausea

Intervention: Saline (Drug); Phenergan (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Christiana Care Health Services

Official(s) and/or principal investigator(s):
Michael Perraut, MD, Principal Investigator, Affiliation: Christiana Care Health Services

Overall contact:
Melissa Bollinger, RN, Phone: (302) 733-4189, Email: mbollinger@christianacare.org

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: Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Determine the rate of adverse reactions with promethazine co-administration compared to placebo, and, if statistically significant, the number needed to harm.

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

Melissa Bollinger, RN, Phone: (302) 733-4189, Email: mbollinger@christianacare.org

Christiana Care Health Services, Newark, Delaware 19718, United States; Recruiting
Melissa Bollinger, RN, Phone: 302-733-4189, Email: mbollinger@christianacare.org
Michael Perraut, MD, Principal Investigator
Andria Lake, RN, Sub-Investigator
John Mohline, DO, Sub-Investigator
Rick Hong, MD, Sub-Investigator
Melissa Bollinger, RN, Sub-Investigator
Additional Information

Starting date: February 2007
Ending date: September 2009
Last updated: December 30, 2008

Page last updated: February 12, 2009

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