Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease

Inclusion Criteria:

• Confirmed diagnosis of any form of SCD, including sickle cell anemia,sickle-hemoglobin C disease, and sickle-ß˖ or ß°-thalassemia

• Currently experiencing an acute painful episode (vaso-occlusive crisis), defined asacute pain in the extremities, back, abdomen, or chest that has lasted at least 4hours and is presumed to be due to SCD, with no other identified cause

• Onset of severe pain in its current location(s) must have occurred within 72 hours ofstudy entry

• Intensity of pain must be great enough to necessitate hospitalization for opioidanalgesia (e.g., failure of home and outpatient therapy)

• Ability to comprehend and use patient-controlled analgesia (PCA)

• Score of 6 or greater on the baseline pain scale

Exclusion Criteria:

• Temperature greater than or equal to 38.5ºC at the time of study entry or in thepreceding 12 hours

• Has a new lobar pulmonary infiltrate or a diagnosis of acute chest syndrome (i.e., anew lobar pulmonary infiltrate and two or more of the following: temperature greaterthan 38ºC, tachypnea, dyspnea, intercostal or supraclavicular retractions, nasalflaring, chest wall pain, and an oxygen saturation of less than 90% in room air bypulse oximetry)

• Diagnosis of acute splenic or hepatic sequestration crisis (i.e., liver or spleenenlarged from steady-state size and Hgb level decreased 2 g/dL or more fromsteady-state value)

• Currently experiencing priapism

• Pain caused by suspected or confirmed hepatobiliary disease (e.g., cholecystitis orcholelithiasis)

• Chronic pain caused by suspected or confirmed aseptic or avascular necrosis of thefemoral or humeral heads

• Chronic pain syndrome characterized by opioid tolerance and defined by hospitalizationfor at least 30 days for the management of pain in a 1 year period prior to studyentry

• Current participation (last transfusion given within the 2 months prior to studyentry) in a program of chronic transfusions for the management of SCD; the use ofhydroxyurea alone is permitted

• Allergy or history of anaphylactoid reactions to aspirin or other NSAIDs

• Kidney dysfunction (i.e., serum creatinine concentration greater than 1.5 times theupper limit of normal for age)

• History of gastrointestinal bleeding or ulceration requiring medical therapy

• Concomitant bleeding disorder (e.g., von Willebrand disease, hemophilia, or aqualitative platelet defect)

• Any other medical condition that would make it unsafe to receive NSAIDs, as determinedby the study physician

• PCA not preferred

• Use of ketorolac in the 30 days prior to study entry

• Use of scheduled (e.g., "around the clock") opioid analgesics in the 5 days before theonset of current acute painful crisis

• Pregnant