Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders
Condition: DeQuervains Tenosynovitis; Lateral Epicondylitis; Tennis Elbow; Trigger Finger; Tenosynovitis; Inflammatory Disease
MeSH terms: Tennis Elbow; Trigger Finger Disorder; Tenosynovitis
Intervention: Ketorolac; Dexamethasone
Intervention description: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Ketorolac is a non-steroidal anti-inflammatory drug (NSAID). The approved indication for Ketorolac is for the short-term (≤5 days) management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. It is highly protein bound (99%) and is largely metabolized by the liver. In it's approved indication it is contraindicated for those with renal impairment, active peptic ulcer disease, pregnant or nursing females, individuals with NSAID hypersensitivity, or individuals at high risk for bleeding/clotting disorders.; Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.
In its approved indication there use limitations for immunocompromised individuals, pregnant females, persons with allergy to steroids, individuals with systemic fungal infections, and individuals with cerebral malaria. It is contra-indicated in systemic fungal infections, and hypersensitivity to any component of this product, including sulfites.
Intervention MeSH terms: Dexamethasone; Ketorolac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DeQuervains Tenosynovitis; Lateral Epicondylitis; Tennis Elbow; Trigger Finger; Tenosynovitis; Inflammatory Disease; Dexamethasone; Ketorolac; Toradol

Summary:

      The primary objective of this study is to compare local corticosteroid hand and elbow
      injections to placebo or ketorolac to determine if there is an equal or better reduction of
      symptoms for common orthopaedic upper extremity disorders including: De Quervain's
      tenosynovitis, trigger fingers, and tennis elbow (lateral epicondylitis). The investigators
      will enroll 780 subjects, divided equally into three arms for each disease process, and
      compare the efficacy of Ketorolac injections to Dexamethasone injections by measuring
      patient's functional status scores and pain scores at 0 weeks, 4 weeks, 8 weeks, 12 weeks,
      and 6 month followup periods, prospectively over time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be diagnosed with at least one of the following: trigger finger, de
             quervain's tenosynovitis, or tennis elbow (lateral epicondylitis)

          -  Patients age 18 years of age or older from all racial/ethnic types

          -  Patient who are both males and females

          -  Study participants will include any New York University employee or students as these
             individuals also can get hand and upper extremity pathology. It will be specifically
             reiterated to them that their academic status or grades, or employment will not be
             affected by their decision to participate in this study. Record of the participation
             cannot be linked to an academic record.

        Exclusion Criteria:

          -  Patients had previous steroid injection at the site in question within 90 days of
             enrollment

          -  Patients with a history of gastric ulcers, renal impairment, allergy/hypersensitivity
             to non-steroidal anti-inflammatory (NSAID) or lidocaine derivative medications,
             immunocompromised patients (HIV/AIDs) and pregnant females