Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .
Valdecoxib for Postoperative Pain Management After Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Study
Although nonsteroidal antiinflammatory drugs ( NSAIDs ) improve postoperative pain relief after cesarean delivery , they carry potential side effects ( e.g. , bleeding ) . Perioperative cyclooxygenase (COX)-2 inhibitors show similar analgesic efficacy to nonsteroidal antiinflammatory drugs in many surgical models but have not been studied after cesarean delivery . We design ed this r and omized double-blind study to determine the analgesic efficacy and opioid-sparing effects of valdecoxib after cesarean delivery . Healthy patients undergoing elective cesarean delivery under spinal anesthesia were r and omized to receive oral valdecoxib 20 mg or placebo every 12 h for 72 h postoperatively . As a result of cyclooxygenase-2 inhibitors safety concerns that became apparent during this study , the study was terminated early after evaluating 48 patients . We found no differences in total analgesic consumption between the valdecoxib and placebo groups ( 121 ± 70 versus 143 ± 77 morphine mg-equivalents , respectively ; P = 0.26 ) . Pain at rest and during activity were similar between the groups despite adequate post hoc power to have detected a clinical ly significant difference . There were also no differences in IV morphine requirements , time to first analgesic request , patient satisfaction , side effects , breast-feeding success , or functional activity . Postoperative pain was generally well controlled . Adding valdecoxib after cesarean delivery under spinal anesthesia with intrathecal morphine is not supported at this time
Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .