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临床试验/NCT02361567
NCT02361567已完成4 期

Comparison of Tramacet Versus Percocet in Post Surgical Patients

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
160
试验地点
1
主要终点
Sought Second Prescription

研究概览

简要总结

Opioid naive patients are randomized to receive either TRAMACET or PERCOCET at the time of discharge following mild to moderate pain risk surgery. The following will be assessed: 1) Brief pain inventory (BPI) for the month. 2) Post operative pain management satisfaction. 3) Whether they sought any repeat opioid prescription. 4) Whether they intend to seek repeat opioid prescription. It is expected that both groups will have similar pain outcomes but those patients in the Percocet group will be more likely to seek a second prescription.

详细描述

Patient operating lists will be screened on a daily basis at identify potential patient candidates. The surgeon of note will be consulted to ensure that each patient, in their opinion, may be a candidate. If approved by the surgeon of note, the patient will then be approached in the preoperative area by a member of the research team to determine if they will consent to enrollment in the study.

Patients will be double blinded and randomized following low to moderate pain surgery (surgery in which patients do not generally require a patient controlled analgesic pump post-operatively, or require post operative analgesia beyond 14 days) to receive either tramacet 1-2 tablets orally every 4 hours prn or percocet 1-2 tablets orally every 4 prn. At time of discharge patients will recieve unidentifiable tablets in an unidentifying container of the usual dispense amount that their surgeon would standardly prescribe(range is usually between 30 and 60 tabs).

At 6 weeks patients will receive a phone call to determine a) brief pain inventory score for the month. B) if they sought a second opioid prescription. C) if they plan to seek a second script. E) satisfaction of post operative pain control on a 1-10 numerical scale f) any adverse side effects.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patients on Opioids
  • Children < 18 years
  • Language barrier
  • Past medical history of psychosis
  • Coexisting use of anti-depressants
  • American Society of Anesthesia Risk Score >3
  • Known allergy to opioid or acetaminophen

研究组 & 干预措施

Tramacet

Active Comparator

Tramacet 1-2 tabs PO q4h prn

干预措施: Tramacet (Drug)

Percocet

Active Comparator

Percocet (5/325) 1-2 tab PO q4h PRN

干预措施: Percocet (Drug)

结局指标

主要结局

Sought Second Prescription

时间窗: 6 weeks post-operative

What patients have sought a second opioid prescription post operatively

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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