Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease
Condition: Hematologic Diseases; Anemia, Sickle Cell
MeSH terms: Anemia, Sickle Cell; Hematologic Diseases
Intervention: Intravenous Ketorolac; Ibuprofen
Intervention description: Intravenous ketorolac; Ibuprofen, taken orally
Intervention MeSH terms: Ibuprofen; Ketorolac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Blood Diseases; Sickle Cell Anemia

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).
    

Eligibility 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