DysphagiaPhase 3NCT04650893
The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF
A Phase 3 study testing Intravenous Ketorolac and Intravenous Dexamethasone in people with Dysphagia and Dysphonia, run by University of Nebraska at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- What is being tested?
- Intravenous Ketorolac and Intravenous Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2021to 8 Dec 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, Lauritzen Outpatient Center
Omaha, Nebraska, 68105
About this study
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
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).
Read the 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 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.
- Being tested
- Intravenous Ketorolac, Intravenous Dexamethasone, Placebo
- Medical subject headings
- Deglutition Disorders, Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous KetorolacDrug
To assess the efficacy of the meds for dysphagia and dysphonia following ACDF
Intravenous DexamethasoneDrug
To assess the efficacy of the meds for dysphagia and dysphonia following ACDF
PlaceboDrug
Control
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | no steroid or non steroidal anti-inflammatory Receives: Drug: Placebo |
| Ketorolac | Active comparator | one time dose of 30mg of IV Ketorolac at time of closure Receives: Drug: Intravenous Ketorolac |
| dexamethasone | Active comparator | one time dose of 10mg of IV dexamethasone at the time of closure Receives: Drug: Intravenous Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: one year
Secondary outcomes (2)
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.
Measured: one year
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. There are 10 sections, and each section contains 6 statements.The statements are scored from 0 to 5, with 0 indicating no disability and 5 indicating complete disability.
0: No disability or difficulty
- Mild disability or difficulty
- Moderate disability or difficulty
- Severe disability or difficulty
- Very severe disability or difficulty
- Complete disability or difficulty
Total Score: The scores from each of the 10 sections are summed to calculate the total score. The maximum possible score is 50, which would indicate severe disability, while a score of 0 indicates no disability.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start2 Jan 2021
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Why it stopped: Poor compliance with data collection - too many intervals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 25 patients into 3 separate arms.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Garvin, MD, Study chair, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650893
- Sponsor's protocol ID
- 0737-19-FB
- Status last verified
- Aug 2024
- First submitted
- 12 Nov 2020
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04650893
- Acronym / sponsor ID
- 0737-19-FB
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor compliance with data collection - too many intervals.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 25 patients into 3 separate arms.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Placebono steroid or non steroidal anti-inflammatory |
| Ketorolac | Active comparator | Drug: Intravenous Ketorolacone time dose of 30mg of IV Ketorolac at time of closure |
| dexamethasone | Active comparator | Drug: Intravenous Dexamethasoneone time dose of 10mg of IV dexamethasone at the time of closure |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous KetorolacTo assess the efficacy of the meds for dysphagia and dysphonia following ACDF | Drug | Ketorolac |
| Intravenous DexamethasoneTo assess the efficacy of the meds for dysphagia and dysphonia following ACDF | Drug | dexamethasone |
| PlaceboControl | Drug | Control |
Primary outcome
Percentage of Patients With Moderate/Severe Bazaz Classification
Time frame: one year
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)
Time frame: one year
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.
2 secondary outcomes
Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10).
Time frame: one year
Mean Neck Disability Index (NDI)
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Garvin, MD study chair
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous Ketorolac and Intravenous Dexamethasone in people with Dysphagia and Dysphonia, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Moderate/Severe Bazaz Classification (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.