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

114809

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

2020-02-18

2025-02-01

2025-04-01

Recruiting

Early phase I

44

Inclusion Criteria: * Adults 18 years of age or older; * Diagnosis of CRS with nasal polyposis in the setting of AERD, and requiring FESS for management after failing medical management per the Canadian clinical practice guidelines for acute and chronic sinusitis; * Capable, in the opinion of the primary investigator, of providing informed consent to participate in the study. Participants are required to sign an informed consent form indicating they understand the purpose and nature of the study, and that they are willing to participate. Exclusion Criteria: * Known allergies/sensitivities to acetaminophen, opioid, or COX-2 inhibitor NSAIDs * Inability to read and understand English * Inability to keep record of exact use of analgesics post-FESS * History of opioid/narcotic abuse * Known Ischemic Heart Disease * Known Mild to moderate congestive heart failure * Stomach ulceration or bleeding * Known Inflammatory bowel disease * Chronic pain or chronic opioid use * Known renal or hepatic impairment * Known coagulopathy * Women who are pregnant or breastfeeding * Known inability to complete follow-up visits * Current participation in another clinical trial at time of initial visit * Use of other medications that impact the serotonin pathway * Use of medications with potential interactions with celecoxib: 1. Anticoagulants (warfarin, clopidogrel, dabigatran, enoxaparin) 2. ACE inhibitors (e.g. captopril, lisinopril) 3. Diuretics (e.g. furosemide) 4. Lithium 5. Cidofovir 6. Carbamazepine 7. Antidepressants

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective, double-blinded, randomized controlled study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "The control group will use a placebo pill, instead of an active drug. The randomization process will be held by the Site's Pharmacy. Hence, the investigators will only have access to a list of randomized numbers, associated with the available drug/placebo pills, to implement during the study.", 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 44, 'type': 'ESTIMATED'}}

2023-06-18