Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
Arginine Therapy for the Treatment of Vaso-Occlusive Events in Children With Severe Sickle Cell Disease
Emory University
21 participants
May 1, 2015
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to determine whether giving extra arginine to patients with sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease pain scores, decrease need for pain medications or decrease length of hospital stay or emergency department visit.
Eligibility
Inclusion Criteria4
- Established diagnosis of sickle cell disease--Hemoglobin SS (Hb-SS) or Sβᴼ-thalassemia
- -21 years of age
- Weight >= 25kg (55lbs)
- Pain requiring medical care in an acute care setting (emergency department (ED), hospital ward, day hospital, clinic) requiring parenteral opioids, not attributable to non-sickle cell causes.
Exclusion Criteria12
- Decision to discharge home from acute care setting.
- Diagnosis of sickle cell disease with any of the following types: hemoglobin SC disease (HbSC), hemoglobin beta thalassemia (Hb-Beta Thal), hemoglobin SD disease (HbSD), hemoglobin SE disease (HbSE), hemoglobin SO disease (HbSO), hemoglobin AS carrier (Hb AS)
- Hemoglobin less than 5 gm/dL
- Immediate Red cell transfusion anticipated
- Renal dysfunction: Creatinine >1.0 or 2 x baseline
- Mental status or neurological changes
- Acute stroke or clinical concern for stroke
- Pregnancy
- Allergy to arginine
- Previous hospitalization < 7 days
- Use of inhaled nitric oxide, sildenafil or arginine within the last 14 days
- Not an appropriate candidate in the investigator's judgement
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Interventions
Arginine will be dispensed intravenously (in the vein) in the standard dose of arginine as 100 mg/kg three times a day for seven days or until discharge. * Loading dose: 200 mg/kg once * Continuous IV: 300 mg/kg/24 hours
Arginine will be dispensed intravenously (in the vein) as an initial bolus (loading) at each specified group dose once, followed by a standard dose of 100mg/kg every 8 hours until discharge or for a total of 21 doses of arginine, whichever comes first.
Arginine will be dispensed intravenously (in the vein) as a continuous IV infusion of 300 mg/kg/24hr
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT02447874