Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Hematologic Diseases, Anemia, Sickle Cell

In brief

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).

Key facts

Study ID

NCT00115336

Run by

Children's Hospital Medical Center, Cincinnati

People needed

10

Starts

2005-01-01

Expected to finish

2008-12-01

Last updated by the study team

2020-10-08

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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