Prevention of Narcotic-induced Nausea With Promethazine, a Randomized, Double-blind Placebo-controlled Trial

Prevention of Narcotic-Induced Nausea

Sponsors

Lead sponsor: Christiana Care Health Services

Source Christiana Care Health Services
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.

Overall Status Terminated
Start Date February 2007
Completion Date November 2009
Primary Completion Date September 2009
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Patients Who Became Nauseated After IV Opiate Administration. 4 hours post opiate administration
Enrollment 25
Condition
Intervention

Intervention type: Drug

Intervention name: Saline

Description: 10 c of saline

Arm group label: 1

Intervention type: Drug

Intervention name: Phenergan

Description: Physician ordered dose

Arm group label: 2

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Michael Perraut, MD Principal Investigator Christiana Care Health Services
Location
facility
Christiana Care Health Services
Location Countries

United States

Verification Date

March 2014

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: 1

Arm group type: Placebo Comparator

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

Arm group label: 2

Arm group type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Double (Participant, Care Provider)

Source: ClinicalTrials.gov