A Randomized Control Trial Study of the Efficacy of Celecoxib Versus Ketorolac for Perioperative Pain Control
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Average Inpatient Postoperative Pain Score
研究概览
简要总结
Randomized control trial between ketorolac versus celecoxib for postoperative pain following hysterectomy.
详细描述
Purpose:
To determine if Celebrex (Celecoxib) is as effective as Toradol (Ketorolac) at controlling postoperative pain when given in addition to standard postoperative pain control regimens.
Rationale:
Toradol (Ketorolac) is currently used by many surgeons as adjuvant therapy in addition to standard narcotics in managing immediate postoperative pain. Toradol (Ketorolac) is a non-steroidal anti-inflammatory drug that acts as a non-selective cyclooxygenase (COX), inhibiting COX-1 and COX-2 isoforms. (Toradol) Ketorolac has been associated with significant complications including postoperative bleeding and acute renal insufficiency. Celebrex (Celecoxib) is a selective COX-2 inhibitor that has been associated with adverse cardiovascular outcomes in patients with pre-existing cardiac disease but not with postoperative bleeding or renal insufficiency. Celebrex (Celecoxib) has also been shown to control postoperative pain but has never been compared to Toradol (Ketorolac).
Population:
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing hysterectomy
排除标准
- •Coronary Artery Disease
- •Peptic Ulcer Disease
- •Chronic Renal Disease
- •Liver disease
- •Alcohol Abuse
- •Daily narcotic usage
- •Narcotic use 24 hours prior to surgery
- •Crohn's Disease
- •History of myocardial infarction
- •History of stroke
- •Preoperative hematocrit less than 24
- •Ulcerative Colitis
- •Diverticulitis
- •Aspirin Allergy
- •Sulfonamide Allergy
- •Pre-operative pain score of greater than 3
- •Patients undergoing procedures that may involve bowel resection or bowel reanastomosis.
- •Allergy to any non-steroidal anti-inflammatory drug
- •Cardiac anomaly or disease
- •Congestive Heart Failure
研究组 & 干预措施
Ketorolac
Patients receiving scheduled ketorolac postoperatively
干预措施: Ketorolac (Drug)
Celecoxib
Patients receiving celebrex preoperative and postoperatively for 7 days
干预措施: Celecoxib (Drug)
结局指标
主要结局
Average Inpatient Postoperative Pain Score
时间窗: 48 hrs following surgery
Pain measured using the Visual Analog Scale, no pain (0-0.4 cm), mild pain(0.5-4.4 cm), moderate pain (4.5-7.4 cm), and severe pain (7.5-10.0 cm). Subscale scoring was not used in analysis but provided as reference for patient and nursing staff.
次要结局
- Average Inpatient Hydromorphone Use(48 hrs following surgery)
- Number of Participants With Perioperative Complications(During and after surgery)
- Return to Activities of Daily Living(2 weeks after discharge)
- Average Inpatient Ondansetron Use(48 hrs following surgery)
- Total Hospital Stay(Following surgery)
- Days of Oral Narcotic Use After Discharge(2 weeks after discharge)
- Number of Oral Narcotic Pills Used After Discharge(2 weeks after discharge)
研究者
Michael Ulm, MD
Priniciple Investigator
University of Tennessee