The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF

Phase 3

Terminated

Interventions: Drug: Placebo
Drug: Intravenous Ketorolac
Drug: Intravenous Dexamethasone

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Control	Placebo	no steroid or non steroidal anti-inflammatory
Ketorolac	Intravenous Ketorolac	one time dose of 30mg of IV Ketorolac at time of closure
dexamethasone	Intravenous Dexamethasone	one time dose of 10mg of IV dexamethasone at the time of closure

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.