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PainPhase 2NCT03256487

Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department

A Phase 2 study testing Buprenorphine and Morphine Sulfate in people with Pain, run by Alameda Health System at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain
What is being tested?
Buprenorphine and Morphine Sulfate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteUnited States
Study dates
26 Sep 2017to 1 Jul 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting
  • Alameda Health System, Highland Hospital

    Oakland, California, 94602

    David K Duong, MD MS, 617-412-5111, dduong@alamedahealthsystem.org

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Conditions
Pain
Being tested
Buprenorphine, Morphine Sulfate
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BuprenorphineDrug

    buprenorphine 0.3mg IV

  • Morphine SulfateDrug

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

Study groups in NCT03256487
Study groupRoleWhat they receive
BuprenorphineExperimentalPatients 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.
Receives: Drug: Buprenorphine
MorphineActive comparatorPatients 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).
Receives: Drug: Morphine Sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain score difference at 60 minutes

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

    Measured: 60 minutes

Secondary outcomes (10)
  1. Pain score difference at 50 minutes

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

    Measured: 50 minutes

  2. Pain score difference at 40 minutes

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

    Measured: 40 minutes

  3. Pain score difference at 30 minutes

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

    Measured: 30 minutes

  4. Pain score difference at 20 minutes

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

    Measured: 20 minutes

  5. Pain score difference at 10 minutes

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

    Measured: 10 minutes

  6. Adverse events

    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)

    Measured: 10, 20, 30, 40, 50, and 60 minutes

  7. Pain reduction

    Pain reduction at each time point. Measured by NRS (time 0) minus NRS (time x)

    Measured: 10, 20, 30, 40, 50, and 60 minutes

  8. Successful analgesia

    Proportion of patients with NRS < 3 at 60 minutes

    Measured: 60 minutes

  9. Repeat dosing

    Proportion of patients requiring reducing of analgesia at 20 minutes

    Measured: 20 minutes

  10. Summed Pain Intensity difference

    Measurement combining relief magnitude and duration in a single score

    Measured: 60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2017
  2. Study start26 Sep 2017
  3. Primary completion1 Feb 2018 (estimated)
  4. Study completion1 Jul 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03256487
Sponsor's protocol ID
IRB17-04172B
Status last verified
Oct 2017
First submitted
18 Aug 2017
Last updated
19 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Buprenorphine and Morphine Sulfate in people with Pain, run by Alameda Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact David Duong, MD MS (510-437-4573, dduong@alamedahealthsystem.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score difference at 60 minutes (time frame: 60 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2017.

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