Recruiting
Phase 2

Buprenorphine vs. Morphine

Sponsor:

Alameda Health System

Code:

NCT03256487

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Buprenorphine

Morphine Sulfate

Study Details

Brief summary:

This study evaluates intravenous (IV) buprenorphine versus IV morphine for the management of severe, acute pain among emergency department (ED) patients. ED patients with severe pain will be randomized in equal proportion to receive IV buprenorphine or IV morphine.

Conditions

Pain

Study ID

NCT03256487

Start date

Sep 26, 2017

Status verified date

Oct, 2017

Completion date

Jul 1, 2018

Anticipated

Primary completion date

Feb 1, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ED patients with acute pain NRS ≥7 warranting IV opioid analgesia (according to ED provider)

Exclusion Criteria:

  • Patient refusal
  • pregnancy

  • level 1 trauma patients
  • patients deemed critically ill by provider
  • patients in custody
  • patients on methadone
  • Patients who have received or taken any short acting opioid medication in the past 12 hours.
  • Patients who have received or taken any long acting opioid medication in the past 24 hours.

Study Design

Enrollment

122 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Buprenorphine

Patients will receive IV buprenorphine 0.3mg diluted to a volume of 10mL with NS in a plastic syringe administered over 3-5 minutes. At 20 minutes, the patient will be asked "would you like more pain medication?" If he/she answers "yes", then he/she will receive a second dose of IV buprenorphine 0.3mg.

active comparator: Morphine

Patients will receive IV morphine 0.1mg/kg (max dose 8mg) diluted to a volume of 10mL with NS in a plastic syringe administered over 3-5 minutes. At 20 minutes, the patient will be asked "would you like more pain medication?" If he/she answers "yes", then he/she will receive a second dose of IV morphine 0.1mg/kg (max dose 8mg).

Interventions

Buprenorphine

buprenorphine 0.3mg IV

Morphine Sulfate

morphine 0.1 mg/kg IV (max 8mg per dose)

Primary outcome measure

  • Pain score difference at 60 minutes [ Time Frame: 60 minutes ]

Central Contacts and Locations

Central contacts

David Duong, MD MS

510-437-4573dduong@alamedahealthsystem.org

Locations

Alameda Health System, Highland Hospital

Recruiting

Oakland, California, United States, 94602

Contacts

David K Duong, MD MS

617-412-5111dduong@alamedahealthsystem.org

More Information

Sponsor

Alameda Health System

Last update posted

Oct 19, 2017

Last verified

Oct, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alameda Health System on 2017-10-19.