Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis of sickle cell disease (SCD).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati; University of Texas Southwestern Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Texas Southwestern Medical Center
• Treatments: Ibuprofen; Ketorolac; Ketorolac Tromethamine

Criteria

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 as acute pain in the extremities, back, abdomen, or chest that has lasted at least 4 hours 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 of study entry

• Intensity of pain must be great enough to necessitate hospitalization for opioid analgesia (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 the preceding 12 hours

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

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

• Currently experiencing priapism

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

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

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

• Current participation (last transfusion given within the 2 months prior to study entry) in a program of chronic transfusions for the management of SCD; the use of hydroxyurea 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 the upper limit of normal for age)

• History of gastrointestinal bleeding or ulceration requiring medical therapy

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

• Any other medical condition that would make it unsafe to receive NSAIDs, as determined by 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 the onset of current acute painful crisis

• Pregnant