Post-operative Pain Management Following Functional Endoscopic Sinus Surgery

0417-18-FB

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 eliminates the need for narcotic pain medications. Patients will be instructed to take an NSAID regimen after surgery and will be instructed to take narcotics only for breakthrough pain.

2020-11-07

2023-05-30

2023-05-30

Terminated

Early phase I

10

Inclusion Criteria: • All patients age 18-65 undergoing functional endoscopic sinus surgery +/- nasal airway surgery (septoplasty and/or inferior turbinate reduction). Exclusion Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, cohort study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

2023-09-06