Trial · NCT04650893
The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF
NCT04650893, Phase 3, Terminated, University of Nebraska; results first posted 2024-08-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF. Trials, record NCT04650893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04650893
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF
- NCT number
- NCT04650893
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 33 participants, actual
- Lead sponsor
- University of Nebraska
- Conditions
- Dysphagia, Dysphonia
- Interventions
- Intravenous Ketorolac, Intravenous Dexamethasone, Placebo
- First posted
- 2020-12-03
- Last updated
- 2024-08-23
- Results first posted
- 2024-08-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Moderate/Severe Bazaz Classification | one year | The Bazaz grading system (0-none; 1-Mild; 2-Moderate; 3-Severe) is used for dysphagia evaluation |
| Primary | Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10) | 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. |
| Secondary | Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10). | one year | Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia. |
| Secondary | Mean Neck Disability Index (NDI) | one year | 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. |
| Other | Median Visual Analogue Scale for Neck Pain | one year | 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). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Moderate/Severe Bazaz Classification | one year | percentage of participants | NUMBER | |
| PRIMARY | Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10) | one year | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10). | one year | No placeholder numbers included; only one participant completed study. | percentage of participants | NUMBER |
| SECONDARY | Mean Neck Disability Index (NDI) | one year | score on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Median Visual Analogue Scale for Neck Pain | one year | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Moderate/Severe Bazaz Classification | Control | 20 | percentage of participants | ||
| Percentage of Patients With Moderate/Severe Bazaz Classification | Ketorolac | 20 | percentage of participants | ||
| Percentage of Patients With Moderate/Severe Bazaz Classification | Dexamethasone | 0 | percentage of participants | ||
| Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10) | Control | 20 | percentage of participants | ||
| Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10) | Ketorolac | 0 | percentage of participants | ||
| Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10) | Dexamethasone | 0 | percentage of participants | ||
| Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10). | Control | 0 | percentage of participants | ||
| Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10). | Ketorolac | 20 | percentage of participants | ||
| Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10). | Dexamethasone | 25 | percentage of participants | ||
| Mean Neck Disability Index (NDI) | Control | 13.2 | Full Range 1 to 28 | score on a scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control | 11 | |
| Overall Study | STARTED | Ketorolac | 10 | |
| Overall Study | STARTED | Dexamethasone | 12 | |
| Overall Study | COMPLETED | Control | 0 | |
| Overall Study | COMPLETED | Ketorolac | 0 | |
| Overall Study | COMPLETED | Dexamethasone | 1 | |
| Overall Study | NOT COMPLETED | Control | 11 | |
| Overall Study | NOT COMPLETED | Ketorolac | 10 | |
| Overall Study | NOT COMPLETED | Dexamethasone | 11 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control | 0 | 11 |
| Total, all-cause mortality | Ketorolac | 0 | 10 |
| Total, all-cause mortality | Dexamethasone | 0 | 12 |
| Total, other adverse events | Control | 0 | 11 |
| Total, other adverse events | Ketorolac | 0 | 10 |
| Total, other adverse events | Dexamethasone | 0 | 12 |
| Total, serious adverse events | Control | 0 | 11 |
| Total, serious adverse events | Ketorolac | 0 | 10 |
| Total, serious adverse events | Dexamethasone | 0 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04650893
GET https://conductscience.org/api/trials/v1/NCT04650893/registered