The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF
Primary Purpose
Dysphagia, Dysphonia
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Intravenous Ketorolac
Intravenous Dexamethasone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia
Eligibility Criteria
Inclusion Criteria:
- 19 years of age and older
- Undergoing ACDF for radiculopathy or myelopathy
- No known allergies or sensitivities to steroid or non-steroidal medications
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 including gastrointestional bleeding...)
- Patients with known kidney disease or a creatinine level above the upper limit of normal >1.27
Sites / Locations
- University of Nebraska Medical Center, Lauritzen Outpatient CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Control
Ketorolac
dexamethasone
Arm Description
no steroid or non steroidal anti-inflammatory
one time dose of 30mg of IV Ketorolac at time of closure
one time dose of 10mg of IV dexamethasone at the time of closure
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Percentage of patients with clinically significant Voice Handicap Index-10 (VHI-10).
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia
Mean Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a 10 item pain intensity and daily activity questionnaire that measures daily limitations after cervical spine injury.
The Neck Disability Index (NDI) is a 10 item pain intensity and daily activity questionnaire that measures daily limitations after cervical spine injury.
The Neck Disability Index (NDI) is a 10 item pain intensity and daily activity questionnaire that measures daily limitations after cervical spine injury.
The Neck Disability Index (NDI) is a 10 item pain intensity and daily activity questionnaire that measure daily limitations after cervical spine injury
Full Information
NCT ID
NCT04650893
First Posted
November 12, 2020
Last Updated
September 29, 2023
Sponsor
University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT04650893
Brief Title
The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Dysphonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
25 patients into 3 separate arms.
Masking
Participant
Masking Description
Only patients will be masked from which cohort they were randomized into.
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
no steroid or non steroidal anti-inflammatory
Arm Title
Ketorolac
Arm Type
Active Comparator
Arm Description
one time dose of 30mg of IV Ketorolac at time of closure
Arm Title
dexamethasone
Arm Type
Active Comparator
Arm Description
one time dose of 10mg of IV dexamethasone at the time of closure
Intervention Type
Drug
Intervention Name(s)
Intravenous Ketorolac
Intervention Description
To assess the efficacy of the meds for dysphagia and dysphonia following ACDF
Intervention Type
Drug
Intervention Name(s)
Intravenous Dexamethasone
Intervention Description
To assess the efficacy of the meds for dysphagia and dysphonia following ACDF
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Control
Primary Outcome Measure Information:
Title
Percentage of patients with Moderate/Severe Bazaz Classification
Description
The Bazaz grading system (0-none; 1-Mild; 2-Moderate; 3-Severe) is used for dysphagia evaluation
Time Frame
one year
Title
Percentage of patients with severe dysphagia based on the Eating Assessment Tool (EAT-10)
Description
Scores on the EAT-10 greater than 15 are indicative of severe dysphonia
Time Frame
one year
Secondary Outcome Measure Information:
Title
Percentage of patients with clinically significant Voice Handicap Index-10 (VHI-10).
Description
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia
Time Frame
one year
Title
Mean Neck Disability Index (NDI)
Description
The Neck Disability Index (NDI) is a 10 item pain intensity and daily activity questionnaire that measures daily limitations after cervical spine injury.
The Neck Disability Index (NDI) is a 10 item pain intensity and daily activity questionnaire that measures daily limitations after cervical spine injury.
The Neck Disability Index (NDI) is a 10 item pain intensity and daily activity questionnaire that measures daily limitations after cervical spine injury.
The Neck Disability Index (NDI) is a 10 item pain intensity and daily activity questionnaire that measure daily limitations after cervical spine injury
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Median Visual Analouge Scale for Neck Pain
Description
The Visual analogue scale is a 10 cm horizontal line, with extremes marked "no pain" (left) and the "worst pain imaginable" (right).
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
19 years of age and older
Undergoing ACDF for radiculopathy or myelopathy
No known allergies or sensitivities to steroid or non-steroidal medications
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 including gastrointestional bleeding...)
Patients with known kidney disease or a creatinine level above the upper limit of normal >1.27
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott A Vincent, MD
Phone
402-559-9171
Email
scott.vincent@unmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Pete W Danielson, BS
Phone
402-559-1703
Email
peter.danielson@unmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Garvin, MD
Organizational Affiliation
University of Nebraska
Official's Role
Study Chair
Facility Information:
Facility Name
University of Nebraska Medical Center, Lauritzen Outpatient Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pete W Danielson, BS
Phone
402-641-4262
Email
peter.danielson@unmc.edu
12. IPD Sharing Statement
Learn more about this trial
The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF
We'll reach out to this number within 24 hrs