Status:
TERMINATED
Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
University of Texas Southwestern Medical Center
Conditions:
Hematologic Diseases
Anemia, Sickle Cell
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief 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...
Detailed Description
BACKGROUND: SCD is a common disorder among African Americans and other minority groups. It is characterized by chronic anemia and episodic vaso-occlusive crises. The most common of these crises is th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00115336
Start Date
January 1 2005
End Date
December 1 2008
Last Update
October 8 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390