A Phase 2 interventional study of Buprenorphine and Morphine Sulfate in Pain, sponsored by Alameda Health System. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-19.
Sponsored by Alameda Health System · Phase 2, Interventional, and Treatment
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.
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's planned enrollment of 122 is above the median of 70 across 2,101 interventional studies indexed under Pain.
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Exclusion Criteria:
pregnancy
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
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
buprenorphine 0.3mg IV
morphine 0.1 mg/kg IV (max 8mg per dose)
Pain score difference at 60 minutes
The difference in pain scores (measured by NRS) between the two arms at 60 minutes.
Time frame: 60 minutes
Pain score difference at 50 minutes
The difference in pain scores (measured by NRS) between the two arms.
Time frame: 50 minutes
Pain score difference at 40 minutes
The difference in pain scores (measured by NRS) between the two arms.
Time frame: 40 minutes
Pain score difference at 30 minutes
The difference in pain scores (measured by NRS) between the two arms.
Time frame: 30 minutes
Pain score difference at 20 minutes
The difference in pain scores (measured by NRS) between the two arms.
Time frame: 20 minutes
Pain score difference at 10 minutes
The difference in pain scores (measured by NRS) between the two arms.
Time frame: 10 minutes
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)
Time frame: 10, 20, 30, 40, 50, and 60 minutes
Pain reduction
Pain reduction at each time point. Measured by NRS (time 0) minus NRS (time x)
Time frame: 10, 20, 30, 40, 50, and 60 minutes
Successful analgesia
Proportion of patients with NRS \< 3 at 60 minutes
Time frame: 60 minutes
Repeat dosing
Proportion of patients requiring reducing of analgesia at 20 minutes
Time frame: 20 minutes
Summed Pain Intensity difference
Measurement combining relief magnitude and duration in a single score
Time frame: 60 minutes
Plan to share: No
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Studies of the drug tested here: Buprenorphine
Alameda Health System