NCT04650893

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This study is to assess the efficacy of intra-operative intravenous non-steroidal anti-inflammatory drug (Ketorolac) versus intravenous (dexamethasone) administration on dysphagia and dysphonia after anterior cervical discectomy and fusion (ACDF).

Detailed description

The purpose of this study is to assess the efficacy of two intra-operative, intravenous medications on dysphagia and dysphonia 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. Participants will be recruited for a prospective, randomized, 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.

Conditions

• Dysphagia
• Dysphonia

Interventions

Type	Name	Description
DRUG	Intravenous Ketorolac	To assess the efficacy of the meds for dysphagia and dysphonia following ACDF
DRUG	Intravenous Dexamethasone	To assess the efficacy of the meds for dysphagia and dysphonia following ACDF
DRUG	Placebo	Control

Timeline

• Start date: 2021-01-02
• Primary completion: 2023-12-08
• Completion: 2023-12-08
• First posted: 2020-12-03
• Last updated: 2024-08-23
• Results posted: 2024-08-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study