Comparison of different loading dose of celecoxib on postoperative anti-inflammation and analgesia in patients undergoing endoscopic nasal surgery-200 mg is equivalent to 400 mg.

OBJECTIVE

To demonstrate the efficacy and noninferiority of loading dose of celecoxib 200 mg compared with 400 mg in pain management after endoscopic nasal surgery.

DESIGN

A prospective randomized controlled study.

SETTING

A university hospital.

PATIENTS

Consecutive 120 patients undergoing endoscopic nasal surgery under general anesthesia were randomly assigned to three groups of 40 patients each, celecoxib 400 mg, celecoxib 200 mg, or a control group with no celecoxib.

INTERVENTIONS

Patients received different doses of celecoxib as described 1 hour before anesthesia. Two celecoxib groups received celecoxib 200 mg every 12 hours until the fifth day after surgery.

OUTCOME MEASURES

Noninferiority could be claimed if the lower limit of the confidence interval (CI) for pain score difference was greater than -0.6. At 0, 6, and 48 hours after surgery, prostaglandin E2 (PGE2) and thromboxane A2 (TXA2) to prostaglandin I2 (PGI2) ratios were measured from incision drainage and in plasma.

RESULTS

Estimated difference between two loading doses for pain scores over 5 days was 0.275 (95%CI -0.255 to 0.805, P > 0.05), indicating the noninferiority of celecoxib 200-400 mg. Local PGE2 at 6 hours and 48 hours positively correlated with pain scores, with correlation coefficients 0.371 (P = 0.005) and 0.288 (P = 0.033). Systemic TXA2 to PGI2 ratios did not differ among groups.

CONCLUSIONS

An initial dose of celecoxib 200 mg was equivalent to celecoxib 400 mg with regard to the margin previously specified at -0.6 in reducing moderate postoperative pain in endoscopic nasal surgery both in analgesic efficacy and anti-inflammatory property. One hundred and twenty patients were included in this prospective randomized controlled study. Patients treated with celecoxib had lower pain scores than controls, pain scores correlating with local PGE2 level. An initial dose of celecoxib 200 mg was equivalent to 400 mg in reducing moderate pain after endoscopic nasal surgery.