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临床试验/NCT03404518
NCT03404518已完成3 期

Quantifying Narcotic Use in Outpatient Otolaryngology Procedures

Loma Linda University2 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2018年2月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
185
试验地点
2
主要终点
Narcotic Usage

研究概览

简要总结

Patient's pain level and narcotic requirements will be evaluated after routine outpatient Otolaryngology procedures. This will be done by having study participants record their pain level and medication usage from home.

详细描述

It is routine practice to give narcotic medication after surgery for pain control however the abuse of prescription medications has become the fastest growing drug problem in the United States. Research has shown that post operative pain for some common Ear, Nose, and Throat (ENT) procedures are not severe but there is limited data looking at patient narcotic needs and their usage pattern to help inform physicians on how much to prescribe.

The objective of this study is to evaluate patient pain level in the immediate post-operative period and quantify pain medication usage in patients who undergo outpatient ENT surgeries.

Patients who undergo the following procedures will be invited to participate: thyroidectomy, parathyroidectomy, parotidectomy, tympanoplasty, mastoidectomy, endoscopic sinus surgery, and septoplasty. All patients will receive Hydrocodone/acetaminophen and Ibuprofen in standard dosage and assigned to one of two groups before surgery. Group 1 will use the narcotic medication for pain control and ibuprofen for breakthrough pain. Group 2 will use ibuprofen for pain control and the narcotic medication for breakthrough. Patients will fill out a data sheet for 7 days recording their pain level three times per day as well as pain medication usage for each day. This will be collected on their first clinic visit after surgery at which point the patient's involvement is completed.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing one of the following outpatient procedure:
  • Septoplasty
  • Unilateral or Bilateral Functional endoscopic sinus surgery
  • Tympanomastoidectomy
  • Tympanoplasty
  • Total or Partial Thyroidectomy
  • Parathyroidectomy
  • Parotidectomy.
  • Age >18 years and < 89 years

排除标准

  • Age < 18 years or > 89 years
  • Post operative hospital admission
  • Allergy to Hydrocodone
  • Allergy or contraindication to Ibuprofen or NSAIDs
  • Pregnancy
  • Hepatic disease
  • Chronic kidney disease
  • Sickle cell anemia

研究组 & 干预措施

Norco and Ibuprofen

Experimental

This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention.

If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.

干预措施: Norco (Drug)

Ibuprofen and Norco

Active Comparator

This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention.

If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.

干预措施: Ibuprofen (Drug)

结局指标

主要结局

Narcotic Usage

时间窗: First 7 days after surgery

The average number of narcotic pills needed or used for pain control

次要结局

  • Ibuprofen Usage(First 7 days after surgery)
  • Patient Pain Level(Average reported pain for first 7 days after surgery)

研究者

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

Jared Inman

Associate Professor

Loma Linda University

研究点 (2)

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