NCT03256487

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 26, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

August 18, 2017

Last Update Submit

October 17, 2017

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain score difference at 60 minutes

    The difference in pain scores (measured by NRS) between the two arms at 60 minutes.

    60 minutes

Secondary Outcomes (10)

  • Pain score difference at 50 minutes

    50 minutes

  • Pain score difference at 40 minutes

    40 minutes

  • Pain score difference at 30 minutes

    30 minutes

  • Pain score difference at 20 minutes

    20 minutes

  • Pain score difference at 10 minutes

    10 minutes

  • +5 more secondary outcomes

Study Arms (2)

Buprenorphine

EXPERIMENTAL

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.

Drug: Buprenorphine

Morphine

ACTIVE COMPARATOR

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).

Drug: Morphine Sulfate

Interventions

BuprenorphineDRUG

buprenorphine 0.3mg IV

Buprenorphine
Morphine SulfateDRUG

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

Morphine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alameda Health System, Highland Hospital

Oakland, California, 94602, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

BuprenorphineMorphine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsMorphine Derivatives

Central Study Contacts

David Duong, MD MS

CONTACT

510-437-4573dduong@alamedahealthsystem.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The provider, nurse administering the medication, patient, and research assistant will be masked to the randomization and the drug provided. We will ensure masking by the following mechanisms: drugs will be prepared by the pharmacy staff in identical 10mL syringes; the medication will be diluted to a volume of 10mL with normal saline (NS); and both medications are clear so the syringes will appear identical. Both drugs will be administered over the same period of time, 3-5 minutes.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 18, 2017

First Posted

August 22, 2017

Study Start

September 26, 2017

Primary Completion

February 1, 2018

Study Completion

July 1, 2018

Last Updated

October 19, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)