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The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF

Dysphagia Clinical Trial

Official title:
The Effect of Intravenous Non-steroidal Anti-inflammatory Drugs and Intravenous Corticosteroids on the Likelihood of Dysphagia and Dysphonia Following Anterior Cervical Discectomy and Fusion

Clinical Trial Summary

This study is to assess the efficacy of intraoperative intravenous nonsteroidal anti-inflammatory drug (ketorolac) versus intravenous (dexamethosone) administration on dysphagia and dysphonia after ACDF.

Clinical Trial Description

The purpose of this study is to assess the efficacy of two intraoperative, intravenous medications on dysphagia and dysophonia following anterior cervical discectomy and fusion(ACDF). The medications include Ketorolac, an anti-inflammatory versus dexamethasone, a corticosteroid. Eligibility criteria includes adults aged 19 years of age or older who are scheduled to undergo a ACDF for radiculopathy or myelopathy by Drs. Cornett and Vincent at Nebraska Medicine. Subjects will be recruited for a prospective, randomzed, single-blinded clinical drug study and randomized into three cohorts: (1) control (no steroid or non-steroidal anti-inflammatory (NSAID), (2) IV NSAID(1-time dose of 30mg of IV Ketorolac at time of closure), and (3) IV steroid (1-time dose of 10mg of IV dexamethasone at the time of closure. The primary outcome measures are patient questionnaires which include the EAT-10 and Bazaz classification for dysphagia and VHI-10 for dysphonia. In addition, the Neck Disability Index (NDI) and Visual Analogue Pain Scale (VAS) will also be collected. Research follow-up will be subject completed questionnaires to be collected pre-operatively and then post operation at day 1, 3 weeks, 6 weeks, 3 months, 6 months, and 1 year. Post operative questionnaires may be collected at time of patient follow-up in clinic, by phone or mail. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04650893
Study type Interventional
Source University of Nebraska
Contact Scott A Vincent, MD
Phone 402-559-9171
Email scott.vincent@unmc.edu
Status Recruiting
Phase Phase 3
Start date January 2, 2021
Completion date February 1, 2024
View Details
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