A Phase 3 interventional study of Intravenous Ketorolac and Intravenous Dexamethasone in Dysphagia and Dysphonia, sponsored by University of Nebraska. Terminated at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by University of Nebraska · Phase 3, Interventional, and Treatment
Among 230 studies in Deglutition Disorders with a site in United States — 45 open to participants now, 50 under way, none of them phase 3. Deglutition Disorders · United States.
Among the 230 studies in Deglutition Disorders with a site in United States, this one is the 101st largest by enrollment of the 165 interventional ones, is one of 17 that started in 2021, is one of 6 in phase 3, and was the 155th registered.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's enrollment of 33 is below the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →45 of the 230 studies in Deglutition Disorders with a site in United States are open now, in 3 countries. Each count lists the studies.
Of the 137 Deglutition Disorders studies recruiting now, 74 (54%) set no upper age limit and 27 (20%) stop at 75 or younger; 15 take children under 18; 19 take healthy volunteers.
This study: 19 Years and older · all sexes · healthy volunteers too.
The full table on the hub →230 studies; the count open now beside each. This study's row is marked.
First in 1979; this study’s year is marked. 17 started in 2021.
Median enrollment 50 across the 165 interventional studies, 66 across the 64 observational. Of the 154 that completed or were terminated, 53 (34%) have results posted.
12 of 230 have an industry lead sponsor. The 10 most frequent:
University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
University of Nebraska has 2 studies filed under Deglutition Disorders — fewer than ten, so there is no comparison to draw.
22 of the studies in Deglutition Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05497219University Health Network, TorontoReference Values for Videofluoroscopic Measures of Swallowing | 2026-11-30 |
| NCT06670521University of Colorado, DenverCorticosteroids for Post-Extubation Dysphagia | 2026-11-30 |
| NCT05603897University of MiamiNon-standardized vs. Standardized Screening for Dysphagia | 2026-11-30 |
| NCT05970406Johns Hopkins UniversityHigh Intensity Dysphagia Rehab for Acute Ischemic Stroke Patients | 2026-11-30 |
| NCT02838316Peter Belafsky, MDAutologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) for Tongue Dysphagia | 2026-12 |
Among the 230 studies in Deglutition Disorders with a site in United States, from their registry updates:
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).
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
no steroid or non steroidal anti-inflammatory
Drug: Placebo
one time dose of 30mg of IV Ketorolac at time of closure
Drug: Intravenous Ketorolac
one time dose of 10mg of IV dexamethasone at the time of closure
Drug: Intravenous Dexamethasone
To assess the efficacy of the meds for dysphagia and dysphonia following ACDF
To assess the efficacy of the meds for dysphagia and dysphonia following ACDF
Control
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
Time frame: 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.
Time frame: one year
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.
Time frame: 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 1. Mild disability or difficulty 2. Moderate disability or difficulty 3. Severe disability or difficulty 4. Very severe disability or difficulty 5. 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.
Time frame: one year
Median Visual Analogue Scale for Neck Pain
The Visual analogue scale is a line with numbers underneath it, with extremes marked "no pain" score of 0 (left) and the "worst pain imaginable" score of 10 (right).
Time frame: one year
| Milestone | Control | Ketorolac | Dexamethasone |
|---|---|---|---|
| Started | 11 | 10 | 12 |
| Completed | 0 | 0 | 1 |
| Not completed | 11 | 10 | 11 |
| Withdrew: Lost to follow-up | 11 | 10 | 11 |
The Bazaz grading system (0-none; 1-Mild; 2-Moderate; 3-Severe) is used for dysphagia evaluation
| percentage of participants | Control | Ketorolac | Dexamethasone |
|---|---|---|---|
| Percentage of Patients With Moderate/Severe Bazaz Classification | 20 | 20 | 0 |
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.
| percentage of participants | Control | Ketorolac | Dexamethasone |
|---|---|---|---|
| Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10) | 20 | 0 | 0 |
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
| percentage of participants | Control | Ketorolac | Dexamethasone |
|---|---|---|---|
| Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10). | 0 | 20 | 25 |
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 1. Mild disability or difficulty 2. Moderate disability or difficulty 3. Severe disability or difficulty 4. Very severe disability or difficulty 5. 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.
| score on a scale | Control | Ketorolac | Dexamethasone |
|---|---|---|---|
| Mean Neck Disability Index (NDI) | 13.2 (1 to 28) | 16.2 (3 to 38) | 3.75 (0 to 9) |
The Visual analogue scale is a line with numbers underneath it, with extremes marked "no pain" score of 0 (left) and the "worst pain imaginable" score of 10 (right).
| score on a scale | Control | Ketorolac | Dexamethasone |
|---|---|---|---|
| Median Visual Analogue Scale for Neck Pain | 2.6 (0 to 6) | 3.4 (0 to 6) | 1.75 (0 to 4) |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Ketorolac | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Dexamethasone | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
Baseline was less than desired due to closure of study because follow-up was poor.
| Age, Continuous(years) | Control | Ketorolac | Dexamethasone | Total |
|---|
| Sex: Female, Male(Participants) | Control | Ketorolac | Dexamethasone | Total |
|---|---|---|---|---|
| Female | 7 | 4 | 5 | 16 |
| Male | 4 | 6 | 7 | 17 |
| Race (NIH/OMB)(Participants) | Control | Ketorolac | Dexamethasone | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 11 | 10 | 11 | 32 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Number of participants per study arm(Participants) | Control | Ketorolac | Dexamethasone | Total |
|---|---|---|---|---|
| Count of participants | 11 | 10 | 12 | 33 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2021 to primary completion in Dec 2023, 35 months.
Results were first posted in Aug 2024, 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ketorolac · Dexamethasone