Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department
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|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
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Buprenorphine Drug: Morphine Sulfate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||122 participants|
|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.|
|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|
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.
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)
- 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.
- Pain score difference at 50 minutes [ Time Frame: 50 minutes ]The difference in pain scores (measured by NRS) between the two arms.
- Pain score difference at 40 minutes [ Time Frame: 40 minutes ]The difference in pain scores (measured by NRS) between the two arms.
- Pain score difference at 30 minutes [ Time Frame: 30 minutes ]The difference in pain scores (measured by NRS) between the two arms.
- Pain score difference at 20 minutes [ Time Frame: 20 minutes ]The difference in pain scores (measured by NRS) between the two arms.
- Pain score difference at 10 minutes [ Time Frame: 10 minutes ]The difference in pain scores (measured by NRS) between the two arms.
- 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)
- 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)
- Successful analgesia [ Time Frame: 60 minutes ]Proportion of patients with NRS < 3 at 60 minutes
- Repeat dosing [ Time Frame: 20 minutes ]Proportion of patients requiring reducing of analgesia at 20 minutes
- Summed Pain Intensity difference [ Time Frame: 60 minutes ]Measurement combining relief magnitude and duration in a single score
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
|Contact: David Duong, MD MSemail@example.com|
|United States, California|
|Alameda Health System, Highland Hospital||Recruiting|
|Oakland, California, United States, 94602|
|Contact: David K Duong, MD MS 617-412-5111 firstname.lastname@example.org|