Effect of Celecoxib on Postoperative Analgesia and Disease Severity in AERD Patients With CRS

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborators: London Health Sciences Centre; University of Western Ontario, Canada
• Treatments: Celecoxib; Narcotics

Criteria

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