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

NCT04147013 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 114809
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 2

Brief 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

Conditions

Chronic Rhinosinusitis with Nasal Polyps; Aspirin-exacerbated Respiratory Disease

Keywords

Analgesia; Analgesic opioids; Nasal Polyposis; Treatment

Outcome Measures

Primary Outcomes (3)

• Post FESS changes in the Lund-Kennedy Endoscopic Score (LKES)

  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.

  1 week and 4 weeks post-operatively.

• Post FESS changes in the Peri-Operative Sinus Endoscopy (POSE) score

  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.

  1 week and 4 weeks post-operatively.

• Post FESS changes in the validated Sino-Nasal Outcome Test 22 (SNOT-22) questionnaire

  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.

  1 week and 4 weeks post-operatively.

Secondary Outcomes (1)

• Post FESS changes in the pain level assessed via the 10-point visual analogue scale

  6h after surgery; 24 hours after surgery; 7 days post-surgery (daily); at the 14th day; and at the 21st day.

Other Outcomes (4)

• Amount of analgesic medication taken on postoperative days 0-7, self reported by the patients.

  0- 7 days post-surgery

• Number of epistaxis events, self reported by the patients.

  0 to 4 weeks post-surgery

• Compliance with prescribed nasal saline rinses, self reported by the patients.

  0 to 4 weeks post-surgery

Study Arms (2)

Celecoxib Group

EXPERIMENTAL

Patients will receive the interventional drug for 7 days post endoscopic sinus surgery. These patients will also receive a prescription for tramadol (50 mg PO Q6H PRN x 10 tablets), to be used as needed for breakthrough pain. Patients will also be permitted to take acetaminophen for breakthrough pain as needed and will be encouraged to use acetaminophen prior to narcotic usage. Finally, they will be prescribed a nasal saline rinse, which is to be started on postoperative day one.

Drug: Celecoxib

Control Group

PLACEBO COMPARATOR

Patients will receive the placebo for 7 days post endoscopic sinus surgery. These patients will also receive a prescription for tramadol (50 mg PO Q6H PRN x 10 tablets), to be used as needed for breakthrough pain. Patients will also be permitted to take acetaminophen for breakthrough pain as needed and will be encouraged to use acetaminophen prior to narcotic usage. Finally, they will be prescribed a nasal saline rinse, which is to be started on postoperative day one.

Drug: Placebo

Interventions

Celecoxib DRUG

Patients will receive celecoxib 200 mg PO BID for 7 days post endoscopic sinus surgery, starting on the evening of the day of surgery.

Also known as: Celebrex

Celecoxib Group

Placebo DRUG

Patients will receive placebo PO BID for 7 days post endoscopic sinus surgery, starting on the evening of the day of surgery.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Western University, Canada: collaborator
• London Health Sciences Centre: collaborator

Study Sites (2)

St. Joseph's Healthcare London

London, Ontario, N6A 4V2, Canada

Location

King Abdulaziz University Hospital

Jeddah, Saudi Arabia

Location

Related Publications (9)

• Bhattacharyya N. Incremental health care utilization and expenditures for chronic rhinosinusitis in the United States. Ann Otol Rhinol Laryngol. 2011 Jul;120(7):423-7. doi: 10.1177/000348941112000701.

  PMID: 21859049 BACKGROUND

• Chen Y, Dales R, Lin M. The epidemiology of chronic rhinosinusitis in Canadians. Laryngoscope. 2003 Jul;113(7):1199-205. doi: 10.1097/00005537-200307000-00016.

  PMID: 12838019 BACKGROUND

• Blackwell DL, Lucas JW, Clarke TC. Summary health statistics for U.S. adults: national health interview survey, 2012. Vital Health Stat 10. 2014 Feb;(260):1-161.

  PMID: 24819891 BACKGROUND

• Xu Y, Quan H, Faris P, Garies S, Liu M, Bird C, Kukec E, Dean S, Rudmik L. Prevalence and Incidence of Diagnosed Chronic Rhinosinusitis in Alberta, Canada. JAMA Otolaryngol Head Neck Surg. 2016 Nov 1;142(11):1063-1069. doi: 10.1001/jamaoto.2016.2227.

  PMID: 27606773 BACKGROUND

• Rudmik L, Smith TL, Schlosser RJ, Hwang PH, Mace JC, Soler ZM. Productivity costs in patients with refractory chronic rhinosinusitis. Laryngoscope. 2014 Sep;124(9):2007-12. doi: 10.1002/lary.24630. Epub 2014 Mar 11.

  PMID: 24619604 BACKGROUND

• Church CA, Stewart C 4th, O-Lee TJ, Wallace D. Rofecoxib versus hydrocodone/acetaminophen for postoperative analgesia in functional endoscopic sinus surgery. Laryngoscope. 2006 Apr;116(4):602-6. doi: 10.1097/01.MLG.0000208341.30628.16.

  PMID: 16585866 BACKGROUND

• Zhao H, Feng Y, Wang Y, Yang B, Xing Z. 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. Pain Med. 2011 Aug;12(8):1267-75. doi: 10.1111/j.1526-4637.2011.01196.x. Epub 2011 Aug 3.

  PMID: 21812904 BACKGROUND

• Desrosiers M, Evans GA, Keith PK, Wright ED, Kaplan A, Bouchard J, Ciavarella A, Doyle PW, Javer AR, Leith ES, Mukherji A, Schellenberg RR, Small P, Witterick IJ. Canadian clinical practice guidelines for acute and chronic rhinosinusitis. Executive summary. J Otolaryngol Head Neck Surg. 2011 May;40 Suppl 2:S91-8. No abstract available.

  PMID: 21658336 BACKGROUND

• Wright ED, Agrawal S. Impact of perioperative systemic steroids on surgical outcomes in patients with chronic rhinosinusitis with polyposis: evaluation with the novel Perioperative Sinus Endoscopy (POSE) scoring system. Laryngoscope. 2007 Nov;117(11 Pt 2 Suppl 115):1-28. doi: 10.1097/MLG.0b013e31814842f8.

  PMID: 18075447 BACKGROUND

MeSH Terms

Conditions

Agnosia; Nasal Polyps

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Leigh Sowerby, MD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, double-blinded, randomized controlled study.

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 31, 2019
• Study Start: February 18, 2020
• Primary Completion: February 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); SA (1)