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临床试验/NCT03256487
NCT03256487Unknown2 期

Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department

Alameda Health System1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2017年9月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
122
试验地点
1
主要终点
Pain score difference at 60 minutes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Buprenorphine

Experimental

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.

干预措施: Buprenorphine (Drug)

Morphine

Active Comparator

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).

干预措施: Morphine Sulfate (Drug)

结局指标

主要结局

Pain score difference at 60 minutes

时间窗: 60 minutes

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

次要结局

  • Pain score difference at 50 minutes(50 minutes)
  • Pain score difference at 40 minutes(40 minutes)
  • Pain score difference at 30 minutes(30 minutes)
  • Pain score difference at 20 minutes(20 minutes)
  • Pain score difference at 10 minutes(10 minutes)
  • Adverse events(10, 20, 30, 40, 50, and 60 minutes)
  • Pain reduction(10, 20, 30, 40, 50, and 60 minutes)
  • Successful analgesia(60 minutes)
  • Repeat dosing(20 minutes)
  • Summed Pain Intensity difference(60 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Duong

Principal Investigator

Alameda Health System

研究点 (1)

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