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临床试验/NCT00685295
NCT00685295已完成1 期

Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain in the ED

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Time to Analgesia

研究概览

简要总结

Assess whether transbuccal fentanyl provides more rapid relief of orthopedic pain, than does the comparator Percocet

详细描述

Patients will be initially deemed eligible for study consideration if, after MGH ED nursing triage, an X-ray is ordered for suspected isolated extremity injury and the triage acuity level is "Minor". Study staff (physicians) will monitor the ED registration and triage areas to assess whether triaged patients are potentially eligible.

For ED patients with minor isolated injuries, X-rays are often ordered from triage, where there is a supervising physician (or nurse practitioner) available to examine patients and direct care. Either at triage (for patients undergoing care at that location) or when patients are moved to the ED's Minor Surgery area, the supervising healthcare provider will be approached immediately after that individual's evaluation of the patient, and before any pain medication is administered, to begin the process of eligibility ascertainment.

If the provider agrees that the patient may be a candidate for the study, the next step will be for the provider to ask the patient if study staff may approach to discuss the trial.

If the patient agrees to have study staff approach to discuss the trial, study personnel (all EM resident or Attending-level physicians) will be introduced by healthcare providers to potential subjects. Study staff will then converse with the patients about the study's aims, methodology, and risks, confirming eligibility and determining if patients will consent to participate.

Patients who are approached, but who are determined to be ineligible, will have no data recorded, other than their age and race/ethnicity and the reason they were ineligible.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Arm 1 / Fentora

Experimental

Intervention Group:

Subject receives:

  1. placebo oral/swallowed pill
  2. Fentanyl (Fentora) 100mcg rapidly dissolving transbuccal tablet

干预措施: Fentanyl (Drug)

Arm 2 / Percocet/Prevacid

Active Comparator

Active Comparator Group:

Subject receives:

  1. Oxycodone/APAP (Percocet) 5/325 mg oral/swallowed pill
  2. Lansoprazole 15 mg (Prevacid) comparator rapidly dissolving transbuccal tablet

干预措施: Lansoprazole (Drug)

Arm 2 / Percocet/Prevacid

Active Comparator

Active Comparator Group:

Subject receives:

  1. Oxycodone/APAP (Percocet) 5/325 mg oral/swallowed pill
  2. Lansoprazole 15 mg (Prevacid) comparator rapidly dissolving transbuccal tablet

干预措施: Oxycodone (Drug)

结局指标

主要结局

Time to Analgesia

时间窗: 60 minutes

Time it took for subjects to achieve a pain score reduction of 2 units (on a 0 to 10 scale)

Pain Reduction

时间窗: 60 minutes

Number of subjects who reached pain reduction. A subject was deemed to have reached pain reduction if there was a two-point drop in pain scale (0-10).

次要结局

  • Occurrence of Untoward Opioid Side Effects(120 minutes)

研究者

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

Stephen H. Thomas, MD MPH

Attending Physician

Massachusetts General Hospital

研究点 (1)

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