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

University of Nebraska

Status and phase: Terminated; Phase 3

Conditions: Dysphagia; Dysphonia

Treatments: Drug: Intravenous Ketorolac; Drug: Placebo; Drug: Intravenous Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04650893

0737-19-FB

Details and patient eligibility

About

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).

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

no steroid or non steroidal anti-inflammatory

Treatment:

Drug: Placebo

Ketorolac

Active Comparator group

Description:

one time dose of 30mg of IV Ketorolac at time of closure

Treatment:

Drug: Intravenous Ketorolac

dexamethasone

Active Comparator group

Description:

one time dose of 10mg of IV dexamethasone at the time of closure

Treatment:

Drug: Intravenous Dexamethasone