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

Last updated: August 20, 2024
Sponsor: University of Nebraska
Overall Status: Terminated

Phase

3

Condition

Speech Disorders

Heartburn

Treatment

Intravenous Dexamethasone

Placebo

Intravenous Ketorolac

Clinical Study ID

NCT04650893
0737-19-FB
  • Ages > 19
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 19 years of age and older

  • Undergoing anterior cervical discectomy and fusion (ACDF) for radiculopathy ormyelopathy

  • No known allergies or sensitivities to steroid or non-steroidal medications

Exclusion

Exclusion Criteria:

  • Procedure is being done for revision, trauma, infection or tumor

  • Patients with known diagnosed metabolic diseases (diabetes, pancreatitis, gout,electrolyte imbalances, hypertension, hematological abnormalities includinggastrointestinal bleeding...)

  • Patients with known kidney disease or a creatinine level above the upper limit ofnormal >1.27

Study Design

Total Participants: 33
Treatment Group(s): 3
Primary Treatment: Intravenous Dexamethasone
Phase: 3
Study Start date:
January 02, 2021
Estimated Completion Date:
December 08, 2023

Study 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.

Connect with a study center

  • Lauritzen Outpatient Center

    Omaha, Nebraska 68105
    United States

    Active - Recruiting

  • University of Nebraska Medical Center, Lauritzen Outpatient Center

    Omaha, Nebraska 68105
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.