Pain Clinical Trial
Official title:
Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department
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.
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