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

NCT04650893 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 0737-19-FB
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dysphagia; Dysphonia

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients With Moderate/Severe Bazaz Classification

  The Bazaz grading system (0-none; 1-Mild; 2-Moderate; 3-Severe) is used for dysphagia evaluation

  one year

• Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10)

  Percentage of patients with severe dysphagia based on the Eating Assessment Tool (EAT-10).Scores on the EAT-10 greater than 15 are indicative of severe dysphonia.

  one year

Secondary Outcomes (2)

• Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10).

  one year

• Mean Neck Disability Index (NDI)

  one year

Other Outcomes (1)

• Median Visual Analogue Scale for Neck Pain

  one year

Study Arms (3)

Control

PLACEBO COMPARATOR

no steroid or non steroidal anti-inflammatory

Drug: Placebo

Ketorolac

ACTIVE COMPARATOR

one time dose of 30mg of IV Ketorolac at time of closure

Drug: Intravenous Ketorolac

dexamethasone

ACTIVE COMPARATOR

one time dose of 10mg of IV dexamethasone at the time of closure

Drug: Intravenous Dexamethasone

Interventions

Intravenous Ketorolac DRUG

To assess the efficacy of the meds for dysphagia and dysphonia following ACDF

Ketorolac

Intravenous Dexamethasone DRUG

To assess the efficacy of the meds for dysphagia and dysphonia following ACDF

dexamethasone

Placebo DRUG

Control

Control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• Undergoing anterior cervical discectomy and fusion (ACDF) for radiculopathy or myelopathy
• No known allergies or sensitivities to steroid or non-steroidal medications

You may not qualify if:

• Procedure is being done for revision, trauma, infection or tumor
• Patients with known diagnosed metabolic diseases (diabetes, pancreatitis, gout, electrolyte imbalances, hypertension, hematological abnormalities including gastrointestinal bleeding...)
• Patients with known kidney disease or a creatinine level above the upper limit of normal \>1.27

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center, Lauritzen Outpatient Center

Omaha, Nebraska, 68105, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Dysphonia

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Peter Danielson
• Organization: University of Nebraska Medical Center

peter.danielson@unmc.edu

402-559-1703

Study Officials

• Kevin Garvin, MD

  University of Nebraska

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only patients will be masked from which cohort they were randomized into.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 25 patients into 3 separate arms.

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: December 3, 2020
• Study Start: January 2, 2021
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)