Effect of Celecoxib on Postoperative Narcotic Use and Disease Severity in Patients with Aspirin-exacerbated Respiratory Disease and Chronic Rhinosinusitis: a Randomised Controlled Trial

NCT04147013 Phase 4 ACTIVE_NOT_RECRUITING

This is a proposed randomized prospective study to evaluate both the anti-inflammatory and analgesic effects of a COX-2 inhibitor, celecoxib, in patients with aspirin-exacerbated respiratory disease and Chronic rhinosinusitis following endoscopic sinus surgery. The investigators hypothesize that supplementation with celecoxib can potentially improve surgical outcomes and reduce the postoperative usage of opioid analgesics without an increased risk of bleeding or asthma exacerbation

Details

Lead sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Phase	Phase 4
Status	ACTIVE_NOT_RECRUITING
Enrolment	44
Start date	2020-02-18
Completion	2026-07

Conditions

• Chronic Rhinosinusitis with Nasal Polyps
• Aspirin-exacerbated Respiratory Disease

Interventions

• Celecoxib
• Placebo

Primary outcomes

• Post FESS changes in the Lund-Kennedy Endoscopic Score (LKES) — 1 week and 4 weeks post-operatively.
  The postoperative recovery from FESS will be assessed via the changes in the Lund-Kennedy Endoscopic Score (LKES), measured on two time points throughout the post operative recovery.
• Post FESS changes in the Peri-Operative Sinus Endoscopy (POSE) score — 1 week and 4 weeks post-operatively.
  The postoperative recovery from FESS will be assessed via the changes in the Peri-Operative Sinus Endoscopy (POSE) score, measured on two time points throughout the post operative recovery.
• Post FESS changes in the validated Sino-Nasal Outcome Test 22 (SNOT-22) questionnaire — 1 week and 4 weeks post-operatively.
  The postoperative recovery from FESS will be assessed via the changes in the validated Sino-Nasal Outcome Test 22 (SNOT-22) questionnaire, measured on two time points throughout the post operative recovery.

Countries

Canada, Saudi Arabia