Dysphagia, Dysphonia
Conditions
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 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.
Interventions
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
DRUGPlacebo
Control
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Only patients will be masked from which cohort they were randomized into.
Intervention model description
25 patients into 3 separate arms.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
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 gastrointestinal bleeding...) * Patients with known kidney disease or a creatinine level above the upper limit of normal \>1.27
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Pre-assignment details
Study was terminated early, lack of compliance for follow-up intervals.
Participants by arm
| Arm | Count |
|---|---|
| Control no steroid or non steroidal anti-inflammatory
Placebo: Control | 11 |
| Ketorolac one time dose of 30mg of IV Ketorolac at time of closure
Intravenous Ketorolac: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF | 10 |
| Dexamethasone one time dose of 10mg of IV dexamethasone at the time of closure
Intravenous Dexamethasone: To assess the efficacy of the meds for dysphagia and dysphonia following ACDF | 12 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 10 | 11 |
Baseline characteristics
| Characteristic | — | Ketorolac | Dexamethasone | Total | Control |
|---|---|---|---|---|---|
| Age, Continuous | — years | — | — | — | — |
| Number of participants per study arm | — | 10 Participants | 12 Participants | 33 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | — | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | — | 10 Participants | 11 Participants | 32 Participants | 11 Participants |
| Sex: Female, Male Female | — | 4 Participants | 5 Participants | 16 Participants | 7 Participants |
| Sex: Female, Male Male | — | 6 Participants | 7 Participants | 17 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 | 0 / 12 |
| other Total, other adverse events | 0 / 11 | 0 / 10 | 0 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 | 0 / 12 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Percentage of Patients With Moderate/Severe Bazaz Classification | 20 percentage of participants |
| Ketorolac | Percentage of Patients With Moderate/Severe Bazaz Classification | 20 percentage of participants |
| Dexamethasone | Percentage of Patients With Moderate/Severe Bazaz Classification | 0 percentage of participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10) | 20 percentage of participants |
| Ketorolac | Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10) | 0 percentage of participants |
| Dexamethasone | Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10) | 0 percentage of participants |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Mean Neck Disability Index (NDI) | 13.2 score on a scale |
| Ketorolac | Mean Neck Disability Index (NDI) | 16.2 score on a scale |
| Dexamethasone | Mean Neck Disability Index (NDI) | 3.75 score on a scale |
Secondary
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
Population: No placeholder numbers included; only one participant completed study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10). | 0 percentage of participants |
| Ketorolac | Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10). | 20 percentage of participants |
| Dexamethasone | Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10). | 25 percentage of participants |
Other Pre-specified
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Median Visual Analogue Scale for Neck Pain | 2.6 score on a scale |
| Ketorolac | Median Visual Analogue Scale for Neck Pain | 3.4 score on a scale |
| Dexamethasone | Median Visual Analogue Scale for Neck Pain | 1.75 score on a scale |