The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dysphagia
- Dysphonia
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 25 patients into 3 separate arms.Masking: Single (Participant)Masking Description: Only patients will be masked from which cohort they were randomized into.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04650893
- Collaborators
- Not Provided
- Investigators
- Study Chair: Kevin Garvin, M.D. UNMC