Celecoxib Pain Management Following Superficial Parotidectomy: Opioid Sparing Protocol
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number of oxycodone pills taken
研究概览
简要总结
The goal of this clinical trial is to find out whether pain can be managed after an operation with celecoxib instead of oxycodone. The main question it aims to answer is if use of celecoxib plus Tylenol reduces the need for oxycodone.
Researchers will compare the combination of celecoxib and Tylenol to a placebo to find out whether celecoxib works to manage pain.
Participants will:
- Take celecoxib, or a placebo, plus Tylenol with opioids as needed
- Keep a diary of their pain between visits
- Complete questionnaires
详细描述
Surgeons have a unique opportunity to reduce opioid prescriptions - and therefore potential opioid dependence, morbidity and mortality - by altering prescribing patterns in the perioperative period. This study aims to determine if celecoxib is a viable alternative for acute pain control in the postoperative setting for head and neck surgeries which could significantly reduce the amount of narcotic pain pills in circulation and can be extrapolated to other otolaryngologic procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Ability to understand and the willingness to sign a written informed consent document
- •Willing to comply with all study procedures and be available for the duration of the study
- •Ability to take oral medication
- •Undergoing superficial parotidectomy
- •Individuals at least 18 years of age
- •Adequate organ function as indicated by standard laboratory tests: hematology (complete blood count), clinical chemistry
排除标准
- •History of NSAIDs contraindication (severe congestive heart failure, CABG within 14 days, arrhythmias, significant coronary artery disease, cardiomyopathy, severe hepatic impairment, history of peptic ulcer disease or GI bleeding, use of anticoagulation (other than prophylactic aspirin)
- •History of uncontrolled hypertension, cerebrovascular accident, sulfa allergy, allergy to celecoxib
- •Concurrent use of CYP2C9 potentiator/inhibitor
- •Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
- •Individuals who are pregnant, lactating or planning on becoming pregnant during the study.
- •Not suitable for study participation due to other reasons at the discretion of the investigators.
研究组 & 干预措施
Placebo for pain management
Participants receive placebo in addition to Tylenol and oxycodone
干预措施: Tylenol (Drug)
Celecoxib for pain management
Participants receive celecoxib in addition to Tylenol and oxycodone
干预措施: Oxycodone (Drug)
Celecoxib for pain management
Participants receive celecoxib in addition to Tylenol and oxycodone
干预措施: Celecoxib (Drug)
Placebo for pain management
Participants receive placebo in addition to Tylenol and oxycodone
干预措施: Oxycodone (Drug)
Placebo for pain management
Participants receive placebo in addition to Tylenol and oxycodone
干预措施: placebo (Drug)
Celecoxib for pain management
Participants receive celecoxib in addition to Tylenol and oxycodone
干预措施: Tylenol (Drug)
结局指标
主要结局
Number of oxycodone pills taken
时间窗: 7 days
Total number of oxycodone pills taken during the first 7 days post-operative
次要结局
- Change in pain scores(Baseline (post-operative) to 7 days)
- Drain duration(7 days)
- Number of post-operative complications(7 days)
- Side effects from medications(7 days)