Prevention of Narcotic-Induced Nausea

NCT ID: NCT00541671

Last Updated: 2014-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-11-30

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.

Conditions

Nausea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

10 c of saline

2

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

Group Type: ACTIVE_COMPARATOR

Phenergan

Intervention Type: DRUG

Physician ordered dose

Interventions

Saline

10 c of saline

Intervention Type: DRUG

Phenergan

Physician ordered dose

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Christiana Care Health Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Perraut, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

Christiana Care Health Services

Newark, Delaware, United States

Countries

United States

Other Identifiers

27002

Identifier Type: -

Identifier Source: org_study_id