It is the active comparator in this study. 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.ĭexamethasone 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 highly protein bound (99%) and is largely metabolized by the liver.
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. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID). The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study Most of these side effects are theoretically avoided with local tissue injections. Nonsteroidal anti-inflammatory agents also have their known systemic adverse effects including gastric ulceration and intestinal bleeding as well as impairment of renal function. Given the side-effect profile for corticosteroids it may be beneficial to treat inflammatory disorders with local ketorolac injections. One could argue that the potent anti-inflammatory properties of ketorolac could be used to substitute for local corticosteroid injections in treating certain hand disorders. Studies have shown that ketorolac, a non-steroidal anti-inflammatory agent has a potent anti-inflammatory effect comparable to corticosteroids and a strong analgesic effect allowing for reduced opioid consumption postoperatively (7, 8).
#Torodol shot skin#
Steroid injections are not entirely benign, and complications include tendon ruptures, subcutaneous fat atrophy, skin pigmentation changes, cartilage damage, and hyperglycemic responses in diabetics (9-11, 22-23). Decreasing the inflammatory response by use of splinting, physiotherapy, systemic anti-inflammatory agents, and local anti-inflammatory injections helps to alleviate some or all of the discomfort (2-4).
The inflammatory processes of these disorders cause discomfort and functional impairment for patients. In total, there will be approximately 780 patients enrolled among all treatment arms.ġ.1 Background Many orthopaedic hand disorders are comprised of different forms of tendonitis, tenosynovitis, and arthritis. trigger finger, De Quervain's disease, and tennis elbow).
To account for an estimated 30% loss to follow-up, the investigators plan to enroll a total of 260 patients per treatment arm (i.e. A power analysis indicated that a total sample size of 200 patients randomized equally (1:1 randomization) to each treatment arm (i.e trigger finger, De Quervain's disease, and tennis elbow) without any blocking or stratification would provide 80% statistical power (alpha=.05, beta=0.20) to detect a 10% difference in mean Quick Disabilities of the Arm, Shoulder and Hand (quickDASH) scores between cohorts assuming a common standard deviation of 25% (effect size = 10/25 = 0.4). Statistical Methodology: The sample size as stated above was derived by a power analysis. 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine.Reference therapy: Standard of care peritendinous soft tissue injection for De Quervain's tenosynovitis, trigger fingers, and lateral epicondylitis: 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine Duration of administration Single administration, with a second injection permitted only once as subject desires due to no major clinical response at the 4 or 8-week follow-up.Study Product, Dose, Route, Regimen: Peritendinous soft tissue injection for De Quervain's tenosynovitis, trigger fingers and lateral epicondylitis: 260 subjects in each of the 3 treatment groups (De Quervain's tenosynovitis, trigger fingers and lateral epicondylitis) Diagnosis and Main Inclusion Criteria Subjects 18 years or older, with any of the following diagnoses: De Quervain's tenosynovitis, trigger fingers, or lateral epicondylitis.Objectives: 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). Why Should I Register and Submit Results?.
0 kommentar(er)
