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Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03256487
Recruitment Status : Unknown
Verified October 2017 by David Duong, Alameda Health System.
Recruitment status was:  Recruiting
First Posted : August 22, 2017
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
David Duong, Alameda Health System

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Buprenorphine Drug: Morphine Sulfate Phase 2

Detailed Description:

Buprenorphine is classified as a partial mu opioid agonist and a weak kappa antagonist. In lower doses, buprenorphine has an analgesic potency 25 to 40 times more potent than similar milligram dosages of morphine. Consistent with its partial agonist activity, an apparent ceiling effect for opioid-induced ventilatory impairment has been demonstrated. These properties would suggest that buprenorphine is an effective analgesic with a favorable safety profile.

Objective: The objective of this study is to determine if there is a clinically significant difference in reduction of pain scores, measured by the Numeric Rating Scale (NRS), between intravenous (IV) buprenorphine and IV morphine for severe pain in patients presenting to the Alameda Health System--Highland Hospital ED. The investigators are evaluating if IV buprenorphine is non-inferior to IV morphing. The investigators hypothesize that buprenorphine will provide equivalent analgesic effects as morphine at 60 minutes, with a lower proportion of medication adverse effects.

Study Design: This is a double-blinded, randomized controlled non-inferiority trial comparing the analgesic efficacy of intravenous buprenorphine versus intravenous morphine for ED patients presenting with severe, acute pain.

Participants: ED patients aged ≥18 years old who present with severe (pain NRS ≥7), acute pain warranting (according the treating provider's judgment) and able to receive IV opioid analgesia. The investigators will exclude pregnant patients, patients deemed too critically ill by the provider, patients with allergy to buprenorphine or morphine, patients in custody, patients on methadone, patients who have taken/received short acting opioid medications in the last 12 hours, and patients who have taken/received long acting opioid medication in the past 24 hours.

Intervention: In arm A, patients will receive IV Buprenorphine 0.3mg diluted to a volume of 10mL with NS in a plastic syringe administered over 3-5 minute. In arm B, patients will receive IV morphine 0.1mg/kg (max 10mg) over 3-5 minutes. In both arms, 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 the same amount of medication they previously received based on the randomized arm they were placed into. At the end of the study time, 60 minutes, the patient's ongoing pain management will be left to the attending physician caring for the patient in the ED.

Data Collection: For both arms, the patients' NRS pain scores and adverse effects will be queried at times 0, 10min, 20 min, 30min, 40min, 50 min, and 60 min. Demographic and comorbidity data points will be abstracted during or after the study's conclusion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department
Actual Study Start Date : September 26, 2017
Estimated Primary Completion Date : February 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Buprenorphine
buprenorphine 0.3mg IV

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).
Drug: Morphine Sulfate
morphine 0.1 mg/kg IV (max 8mg per dose)




Primary Outcome Measures :
  1. Pain score difference at 60 minutes [ Time Frame: 60 minutes ]
    The difference in pain scores (measured by NRS) between the two arms at 60 minutes.


Secondary Outcome Measures :
  1. Pain score difference at 50 minutes [ Time Frame: 50 minutes ]
    The difference in pain scores (measured by NRS) between the two arms.

  2. Pain score difference at 40 minutes [ Time Frame: 40 minutes ]
    The difference in pain scores (measured by NRS) between the two arms.

  3. Pain score difference at 30 minutes [ Time Frame: 30 minutes ]
    The difference in pain scores (measured by NRS) between the two arms.

  4. Pain score difference at 20 minutes [ Time Frame: 20 minutes ]
    The difference in pain scores (measured by NRS) between the two arms.

  5. Pain score difference at 10 minutes [ Time Frame: 10 minutes ]
    The difference in pain scores (measured by NRS) between the two arms.

  6. Adverse events [ Time Frame: 10, 20, 30, 40, 50, and 60 minutes ]
    Hypertension (SBP > 180) from documented vital signs,hypotension (SBP <90) from documented vital signs, hypoxia (oxygen saturation < 90%), respiratory depression (RR<8 or need for mechanical intervention), nausea, vomiting, symptoms of opiate withdrawal (diarrhea, abdominal pain, diaphoresis)

  7. Pain reduction [ Time Frame: 10, 20, 30, 40, 50, and 60 minutes ]
    Pain reduction at each time point. Measured by NRS (time 0) minus NRS (time x)

  8. Successful analgesia [ Time Frame: 60 minutes ]
    Proportion of patients with NRS < 3 at 60 minutes

  9. Repeat dosing [ Time Frame: 20 minutes ]
    Proportion of patients requiring reducing of analgesia at 20 minutes

  10. Summed Pain Intensity difference [ Time Frame: 60 minutes ]
    Measurement combining relief magnitude and duration in a single score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256487


Contacts
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Contact: David Duong, MD MS 510-437-4573 dduong@alamedahealthsystem.org

Locations
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United States, California
Alameda Health System, Highland Hospital Recruiting
Oakland, California, United States, 94602
Contact: David K Duong, MD MS    617-412-5111    dduong@alamedahealthsystem.org   
Sponsors and Collaborators
Alameda Health System
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Responsible Party: David Duong, Principal Investigator, Alameda Health System
ClinicalTrials.gov Identifier: NCT03256487    
Other Study ID Numbers: IRB17-04172B
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Morphine
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists