Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
Recruiting · NCT02447874 · Interventional (participants receive a specific treatment) · Lead sponsor: Emory University
View the official record on ClinicalTrials.gov →Interventions studied
ArginineArginine (Continuous)Arginine (Loading)
What this trial is about
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.
Who can take part
Age range
7 Years to 21 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Established diagnosis of sickle cell disease--Hemoglobin SS (Hb-SS) or Sβᴼ-thalassemia
- 7-21 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 criteria
- 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
Where it is running
2 locations listed across 1 US state.
- Children's Healthcare fo Atlanta at Hughes Spalding - Atlanta, Georgia, United States
- Children's Healthcare of Atlanta at Arthur M. Blank Hospital - Atlanta, Georgia, United States