Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
ConditionSickle Cell Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age7-21
SponsorEmory University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Arginine
- Arginine (Loading)
- Arginine (Continuous)
Treatment groups
21 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Emory University
Lead sponsor
Children's Healthcare of Atlanta
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov