Trial Outcomes & Findings for The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF (NCT NCT04650893)
NCT ID: NCT04650893
Last Updated: 2024-08-23
Results Overview
The Bazaz grading system (0-none; 1-Mild; 2-Moderate; 3-Severe) is used for dysphagia evaluation
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
33 participants
Primary outcome timeframe
one year
Results posted on
2024-08-23
Participant Flow
Study was terminated early, lack of compliance for follow-up intervals.
Participant milestones
| Measure |
Control
no steroid or non steroidal anti-inflammatory
Placebo: Control
|
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 anterior cervical discectomy and fusion (ACDF).
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
12
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
11
|
Reasons for withdrawal
| Measure |
Control
no steroid or non steroidal anti-inflammatory
Placebo: Control
|
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 anterior cervical discectomy and fusion (ACDF).
|
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
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
10
|
11
|
Baseline Characteristics
Age data was not collected
Baseline characteristics by cohort
| Measure |
Control
n=11 Participants
no steroid or non steroidal anti-inflammatory
Placebo: Control
|
Ketorolac
n=10 Participants
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
|
Dexamethasone
n=12 Participants
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
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Female
|
7 Participants
n=11 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=12 Participants
|
16 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=11 Participants
|
6 Participants
n=10 Participants
|
7 Participants
n=12 Participants
|
17 Participants
n=33 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=11 Participants
|
10 Participants
n=10 Participants
|
11 Participants
n=12 Participants
|
32 Participants
n=33 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=33 Participants
|
|
Number of participants per study arm
|
11 Participants
n=11 Participants
|
10 Participants
n=10 Participants
|
12 Participants
n=12 Participants
|
33 Participants
n=33 Participants
|
PRIMARY outcome
Timeframe: one yearThe Bazaz grading system (0-none; 1-Mild; 2-Moderate; 3-Severe) is used for dysphagia evaluation
Outcome measures
| Measure |
Control
n=5 Participants
no steroid or non steroidal anti-inflammatory
Placebo: Control
|
Ketorolac
n=5 Participants
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
|
Dexamethasone
n=4 Participants
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
|
|---|---|---|---|
|
Percentage of Patients With Moderate/Severe Bazaz Classification
|
20 percentage of participants
|
20 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: one yearPercentage 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.
Outcome measures
| Measure |
Control
n=5 Participants
no steroid or non steroidal anti-inflammatory
Placebo: Control
|
Ketorolac
n=5 Participants
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
|
Dexamethasone
n=4 Participants
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
|
|---|---|---|---|
|
Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10)
|
20 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: one yearPopulation: No placeholder numbers included; only one participant completed study.
Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia.
Outcome measures
| Measure |
Control
n=5 Participants
no steroid or non steroidal anti-inflammatory
Placebo: Control
|
Ketorolac
n=5 Participants
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
|
Dexamethasone
n=4 Participants
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
|
|---|---|---|---|
|
Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10).
|
0 percentage of participants
|
20 percentage of participants
|
25 percentage of participants
|
SECONDARY outcome
Timeframe: one yearThe 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.
Outcome measures
| Measure |
Control
n=5 Participants
no steroid or non steroidal anti-inflammatory
Placebo: Control
|
Ketorolac
n=5 Participants
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
|
Dexamethasone
n=4 Participants
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
|
|---|---|---|---|
|
Mean Neck Disability Index (NDI)
|
13.2 score on a scale
Interval 1.0 to 28.0
|
16.2 score on a scale
Interval 3.0 to 38.0
|
3.75 score on a scale
Interval 0.0 to 9.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: one yearThe 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).
Outcome measures
| Measure |
Control
n=5 Participants
no steroid or non steroidal anti-inflammatory
Placebo: Control
|
Ketorolac
n=5 Participants
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
|
Dexamethasone
n=4 Participants
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
|
|---|---|---|---|
|
Median Visual Analogue Scale for Neck Pain
|
2.6 score on a scale
Interval 0.0 to 6.0
|
3.4 score on a scale
Interval 0.0 to 6.0
|
1.75 score on a scale
Interval 0.0 to 4.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketorolac
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place