Status:
TERMINATED
Pain Management Following Sinus Surgery
Lead Sponsor:
University of Nebraska
Conditions:
Nasal Sinus; Inflammation
Opioid Abuse
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
This Study evaluates the effect of adding Non-steroidal anti-inflammatories (NSAIDs) to the post-operative pain management of sinus surgery patients and wether or not this addition reduces or eliminat...
Detailed Description
National attention has been given to the concerning rise of opioid abuse in this country, with prescriptions for this medications more than quadrupaling in the last 17 years. Little is known as to th...
Eligibility Criteria
Inclusion
- • All patients age 18-65 undergoing functional endoscopic sinus surgery +/- nasal airway surgery (septoplasty and/or inferior turbinate reduction).
Exclusion
- Not taking anti-coagulation medications including aspirin
- Clinical Diagnosis of aspirin-exacerbated respiratory disease
- Clinical Diagnosis of Cystic Fibrosis
- Clinical Diagnosis of Primary Ciliary Dyskinesia
- Inclusion of a Draf III frontal sinusotomy
- Clinical Diagnosis of Liver/Kidney Failure
- Clinical Diagnosis of Thrombocytopenia
- Clinical Diagnosis of Poorly controlled hypertension
- Clinical Diagnosis of Recent GI ulcers or gastritis
- Clinical Diagnosis of Chronic pain as defined by a narcotic prescription with 6 months or involvement in a pain management program
- Clinical Diagnosis of Primary Headache disorder
- The use of nasal decongestants in the post-operative period.
- The use of nasal packing or absorbable biomaterials.
Key Trial Info
Start Date :
November 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03822962
Start Date
November 7 2020
End Date
May 30 2023
Last Update
September 6 2023
Active Locations (2)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
2
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0528