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Recruiting Phase 1 / Phase 2

Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease

About this study

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.

Condition
Sickle Cell Disease
Tested
Arginine, Arginine (Loading), Arginine (Continuous)
Sponsor
Emory University

Who can join

Age
7 to 21 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 7

  • Minimum age: 7 years
  • Maximum age: 21 years
  • Study condition: Sickle Cell Disease
  • 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 12

  • 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

2 sites, 2 recruiting

Children's Healthcare fo Atlanta at Hughes Spalding

Atlanta, Georgia, United States

Recruiting

Children's Healthcare of Atlanta at Arthur M. Blank Hospital

Atlanta, Georgia, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.