Analgesic efficacy of Perioperative celecoxib in ambulatory arthroscopic knee surgery: A double-blind, placebo-controlled study

被引:53
作者
Ekman, Evan F.
Wahba, Mona
Ancona, Frank
机构
[1] So Orthoped Sports Med, Columbia, SC 29204 USA
[2] Pfizer Global Pharmaceut, New York, NY USA
关键词
COX-2 selective inhibitors; celecoxib; efficacy; knee arthroscopy; opioid utilization;
D O I
10.1016/j.arthro.2006.03.012
中图分类号
R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学(修复外科学)];
学科分类号
摘要
Purpose: To examine whether celecoxib, administered peri operatively, reduces opioid consumption and opioid-related adverse effects, and provides effective analgesia, in patients undergoing ambulatory arthroscopic knee meniscectomy. Methods: Patients (>= 18 years) with diagnosed knee meniscus disease were given celecoxib (400 mg; n = 99) or placebo (n = 101) 1 hour before they underwent arthroscopic knee surgery; this was followed by celecoxib (200 mg) or placebo given postoperatively at their first request for pain medication. Surgery was performed with patients under general anesthesia (fentanyl, 1 to 3 mu g/kg plus 0.25% intra-articular bupivacame, 10 to 20 mL) administered at the index joint. Every 4 to 6 hours, patients were allowed 1 to 2 tablets of hydrocodone bitartrate 5 mg/acetaminophen 500 mg (and optional opioids as needed). All efficacy analyses were conducted in the modified intent-to-treat population. Results: In the 24 hours following surgery, total opioid consumption was significantly reduced in the celecoxib group (3.6 tablets) compared with the placebo group (4.6 tablets; P = .009). Celecoxib was associated with significant reductions in opioid consumption compared with placebo at 10 to 12 hours (P = .005) and at 12 to 24 hours (P = .012). The percentage of placebo-treated patients (41%) who required opioid analgesics was significantly greater than the percentage of celecoxib-treated patients who required opioids (22%; P = .008) at 10 to 12 hours. Adverse events (AEs) were experienced by more patients in the placebo group (37%) than in the celecoxib group (18%). Incidences of opioid-related events, such as central nervous system disorders (12% v 3%, respectively) and constipation (5% v 1%, respectively), were higher in placebo-treated patients than in those given celecoxib. Conclusions: Perioperative administration of celecoxib plus optional opioids reduces the use of opioids and the occurrence of opioid-related AEs compared with treatment with placebo plus optional opioids given to patients undergoing arthroscopic knee meniscectomy. Level of Evidence: Level 1, randomized, double-blind, placebo-controlled, parallel-group study.
引用
收藏
页码:635 / 642
页数:8
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