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临床试验/NCT02643355
NCT02643355已完成不适用

Utility of Olanzapine in the Treatment of Opioid Withdrawal in the Emergency Department

Hennepin Healthcare Research Institute1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Number of Participants That Received Rescue Medication for Withdrawal Symptoms Within 1 Hour

研究概览

简要总结

Withdrawal from opioids is a clinical scenario that emergency department physicians encounter frequently. Patients who present with opioid withdrawal display symptoms such as agitation, anxiety, myalgias, abdominal pain, diarrhea, nausea, and vomiting. Currently, the standard treatment for opioid withdrawal is clonidine (an alpha-2 adrenergic agonist), as well as supportive cares (anti-emetics, intravenous fluids). Olanzapine is an atypical antipsychotic that is given frequently in the ED for many of the same symptoms that are seen in patients who are experiencing opioid withdrawal, however its use in this toxidrome has never been studied. The hypothesis of this study is that olanzapine is a safe and efficacious option when compared to clonidine for the treatment of opioid withdrawal in the emergency department.

详细描述

This study will be a randomized control trial where patients will be randomized to receive intramuscular olanzapine or oral clonidine as the first intervention given for treatment of opiate withdrawal. This study will not be blinded.

Screening and enrollment: Research Associates will screen patients by review of the electronic medical record. When these patients are identified, the RA will approach the CITI trained ED provider who will obtain written informed consent. Allergies to either medication will be screened for in Epic by the research associates. Allergies will also be verified by the provider who is completing the consent.

Study protocol: If the patient consents to enroll in the study, the research associate will randomize the patient to receive olanzapine or clonidine as the first treatment intervention. The ED provider will then order that medication for the patient and will it be administered by nursing staff. At this time the provider may order the patient to have a peripheral IV placed and IV fluids administered at their discretion. No other supportive measures (anti-emetics, non-narcotic pain medications) may be given at this time.

Prior to medication administration, the research associate will assess the patient's withdrawal symptoms using the Clinical Opiate Withdrawal Scale for withdrawal symptoms. This is a validated tool used to assess degree of withdrawal symptoms by evaluating physiologic and symptomatic parameters. The medical provider will also obtain information regarding the patients opioid use history (what type of opioid used, chronicity of use, date and time of last use). After the study medication administration, patients will be observed for clinical improvement. At 30 minutes, additional medications or interventions may be prescribed at the discretion of the ED provider for symptom control, including crossover of the study medications. The research associate will record which other medications/interventions were ordered, the indication for these interventions, and times administered.

Symptoms will be re-assessed by the research associate using the COWS at 60 minutes, 120 minutes post administration of the initial treatment intervention, as well as at 4 hours post administration (approximately time of discharge from the emergency depatment). At these same time marks, sedation of the patient will be assessed using the overt agitation severity scale (OASS). Throughout the patient's ED stay, the research associate will be monitoring for adverse complications such as allergic reaction, dystonia, akathisia, respiratory complications, or hypotension.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Any patients who present to the emergency department where the providers are concerned for opioid withdrawal contributing to their symptoms on presentation is eligible for inclusion.

排除标准

  • Age less than 18
  • Allergy to either medication (olanzapine, clonidine)
  • Inability to give informed consent
  • Known pregnancy

研究组 & 干预措施

Standard of Care - Olanzapine

Experimental

Drug of interest in the study - Olanzapine

干预措施: Olanzapine (Drug)

Standard of Care - Clonidine

Active Comparator

Standard of care - clonidine

干预措施: Clonidine (Drug)

结局指标

主要结局

Number of Participants That Received Rescue Medication for Withdrawal Symptoms Within 1 Hour

时间窗: 1 Hour

Rescue Medication (additional medications given for symptoms) within 1 hour of medication administration

次要结局

  • Clinical Opiate Withdrawal Scale Score at 2 Hours Post Medication(2 hours)
  • Clinical Opiate Withdrawal Scale Score at 1 Hour Post Medication(At 1 hour)
  • Clinical Opiate Withdrawal Scale Score at the Time of Disposition(Time of Disposition (on average within 6 hours))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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