Prevention of Narcotic-Induced Nausea

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00541671
• Other study ID #: 27002
• Status: Terminated
• Phase: N/A
• First received: October 5, 2007
• Last updated: March 12, 2014
• Start date: February 2007
• Est. completion date: November 2009

Study information

• Verified date: March 2014
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: November 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea

Intervention

Drug:
• Saline
10 c of saline
• Phenergan
Physician ordered dose

Locations

Country	Name	City	State
United States	Christiana Care Health Services	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Who Became Nauseated After IV Opiate Administration.		4 hours post opiate administration	No