Postoperative Pain Control in Septum and Sinus Surgery: A Novel Approach.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of Doses of Opiate (Narcotic) Pain Medication
研究概览
简要总结
This study will evaluate if the use of acetaminophen round the clock (scheduled doses) will lead to less opiate use in the first week post-operative (after surgery) in sinus/septum surgery patients. Participants will be randomized like a flip of a coin to either the standard of care pain treatment of acetaminophen 325 mg as needed for pain plus opiates (acetaminophen/hydrocodone) as needed for breakthrough pain; OR to the study arm of acetaminophen 650 mg every 6 hours plus opiates (Oxycodone)as needed for breakthrough pain.
详细描述
Pain control in the postoperative period following septum and/or sinus surgery is controversial, as there is no consensus statement regarding current guidelines to direct clinical practice. Recent legislation limits opioid prescription length to 5 days only, which brings into question whether legislation will affect prescribing practices of physicians and whether or not giving patients an alternative to opiates will be a more efficacious route.
Current prescribing practices for septum and sinus surgery of the Otolaryngology private practice group includes as-needed acetaminophen 325 mg and as-needed acetaminophen/hydrocodone 7.5 mg/325 mg. If it can be demonstrated that use of 650 mg acetaminophen in scheduled doses of every 6 hours can decrease postoperative opiate use in the first week without significantly increase in patient pain, this may be deployed as an effective strategy of pain control as the use of opiates has come under scrutiny and attempts are being made to decrease or limit the use of these medications in the medical setting.
This study would look to demonstrate that scheduled doses of acetaminophen as opposed to reactionary as-needed acetaminophen can control post-operative pain to the point where narcotics would not be necessary.
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
- 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
- 否
入选标准
- •Undergoing primary sinus surgery, primary septum surgery, or primary sinus/septum surgery
- •18 years of age or older
- •Male or female
- •No known allergies to or contraindications to the use of acetaminophen, hydrocodone, or oxycodone
- •Patients discharged to home after surgery
排除标准
- •Undergoing revision sinus, septum, or sinus/septum surgery
- •Younger than 18 years old
- •Allergy or contraindication to acetaminophen, hydrocodone, or oxycodone
- •Patients admitted to the hospital postoperatively for airway monitoring
研究组 & 干预措施
Standard of Care arm
Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
干预措施: Acetaminophen 325 mg Oral Tablet (Drug)
Standard of Care arm
Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
干预措施: Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet (Drug)
Study Arm
Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
干预措施: Acetaminophen 650 mg Oral Tablet (Drug)
Study Arm
Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
干预措施: OxyCODONE 5 mg Oral Tablet (Drug)
结局指标
主要结局
Number of Doses of Opiate (Narcotic) Pain Medication
时间窗: 7 days
Number of doses of opiates (narcotic) pain medication participants took for breakthrough pain in the first postoperative week.
次要结局
- Highest Subjective Pain Score(7 days)
- Lowest Subjective Pain Score(7 days)
- Percentage of Time Participant Experienced Severe Pain(7 days)
- Participant Use of Acetaminophen as Needed(7 days)
- Participant Use of Scheduled Acetaminophen Around the Clock(7 days)
- Chronic Use of Pain Medication(7 days)
- Participant Use of Additional Pain Medication(7 days)
- Types of Other Pain Medication Used(7 days)
研究者
David Seel
Principal Investigator
William Beaumont Hospitals