Single Dose Oral Celecoxib (With or Without Acetaminophen) for Acute Post-operative Pain Following Impacted Third Molar Surgery.
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
- Pain as Assessed by a Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of this study is to compare the effect on postoperative pain of a single agent nonsteroidal anti-inflammatory drug (NSAID) [celecoxib plus placebo] to an NSAID combination [celecoxib plus acetaminophen] administered preemptively to patients prior to impacted third molar surgery. .
详细描述
This randomized, double-blind, placebo-controlled, prospective clinical trial is designed to compare the postoperative pain reduction of a single agent nonsteroidal anti-inflammatory drug (NSAID) and NSAID combination regimen administered preemptively. Subjects will be given a single oral dose of a cyclooxygenase-2 (COX-2) selective inhibitor (celecoxib 200mg), or celecoxib 200 mg in combination with acetaminophen (APAP 1000 mg) 30 to 60 minutes prior to the procedure. Oral surgery involving at least one impacted mandibular third molar will be performed using a combination of intravenous sedation and local anesthesia following UTHealth School of Dentistry (UTSD) surgical protocol. All subjects will be released with identical postoperative instructions and prescriptions for pain management. Nonopioid pain management will be prescribed as follows: 600mg ibuprofen with 500 mg APAP every 6 hours for the first 3 days, then as needed for pain. Subjects will be asked to document medication consumption, postoperative pain and complications for the following 3 days using a Qualtrics survey. An oral and maxillofacial surgery resident or faculty on call can offer emergency intervention with prescription of an opioid analgesic.
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 (Participant, Care Provider)
盲法说明
Patient regimen randomization will be achieved by use of a random number generator. The care provider or clinic faculty/nurse will blindly administer the regimen to the patient prior to procedure. A placebo capsule will be used to mimic the acetaminophen capsule to maintain blinding of care provider and patient. Preemptive medications will be dispensed in disposable containers prior to the start of daily operations. The research member tasked with dispensing will not be involved with the administration of medications to patients on the day of surgery. The PI and other members of the research team will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) physical status classification 1 or 2
- •at least 1 impacted mandibular third molar planned for extraction
排除标准
- •ASA 3 or higher for physical status classification
- •severe pericoronitis associated with third molar to be extracted
- •any known allergies to NSAIDs, aspirin, acetaminophen, sulfa drugs
- •history of cardiovascular or cerebrovascular disease
- •hepatic disease or impairment
- •pregnancy
研究组 & 干预措施
Celecoxib plus Placebo
Single oral dose of celecoxib 200 mg with placebo 30 to 60 minutes prior to the dental procedure
干预措施: Celecoxib (Drug)
Celecoxib plus Placebo
Single oral dose of celecoxib 200 mg with placebo 30 to 60 minutes prior to the dental procedure
干预措施: Placebo (Drug)
Celecoxib plus Acetaminophen
Single oral dose of celecoxib 200 mg in combination with acetaminophen 1000 mg 30 to 60 minutes prior to the dental procedure.
干预措施: Celecoxib (Drug)
Celecoxib plus Acetaminophen
Single oral dose of celecoxib 200 mg in combination with acetaminophen 1000 mg 30 to 60 minutes prior to the dental procedure.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Pain as Assessed by a Visual Analogue Scale (VAS)
时间窗: 72 hours after procedure
Psychometric response scale to be included in a questionnaire to evaluate pain intensity. A 0-10 pain scale will be used with visual "Faces" to correspond with the numerical values, with 10 indicating worse pain.
次要结局
- Pain as Assessed by a Categorical Descriptive Questionnaire(72 hours after procedure)
- Number of Participants Who Receive an Emergency Analgesic Intervention(Any time during the 72 hours after procedure)
研究者
Harry Gilbert, DDS
DDS, Professor - Oral and Maxillofacial Surgery
The University of Texas Health Science Center, Houston