Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04650893
Status:
TERMINATED
Last Update Posted:
2023-10-02
First Post:
2020-11-12
Brief Title:
The Effect of IV NSAIDs and Corticosteroids on Dysphasia and Dysphonia Following ASDF
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor compliance with data collection - too many intervals
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 NSAID1-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None