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Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department

Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03256487
Enrollment
122
Registered
2017-08-22
Start date
2017-09-26
Completion date
2018-07-01
Last updated
2017-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

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.

Interventions

DRUGBuprenorphine

buprenorphine 0.3mg IV

DRUGMorphine Sulfate

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

Sponsors

Alameda Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain score difference at 60 minutes60 minutesThe difference in pain scores (measured by NRS) between the two arms at 60 minutes.

Secondary

MeasureTime frameDescription
Pain score difference at 40 minutes40 minutesThe difference in pain scores (measured by NRS) between the two arms.
Pain score difference at 30 minutes30 minutesThe difference in pain scores (measured by NRS) between the two arms.
Pain score difference at 20 minutes20 minutesThe difference in pain scores (measured by NRS) between the two arms.
Pain score difference at 10 minutes10 minutesThe difference in pain scores (measured by NRS) between the two arms.
Pain score difference at 50 minutes50 minutesThe difference in pain scores (measured by NRS) between the two arms.
Pain reduction10, 20, 30, 40, 50, and 60 minutesPain reduction at each time point. Measured by NRS (time 0) minus NRS (time x)
Successful analgesia60 minutesProportion of patients with NRS \< 3 at 60 minutes
Repeat dosing20 minutesProportion of patients requiring reducing of analgesia at 20 minutes
Summed Pain Intensity difference60 minutesMeasurement combining relief magnitude and duration in a single score
Adverse events10, 20, 30, 40, 50, and 60 minutesHypertension (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)

Countries

United States

Contacts

Primary ContactDavid Duong, MD MS
dduong@alamedahealthsystem.org510-437-4573

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026