Arginine treatment for pain relief in children with sickle cell disease
Official title: Arginine Therapy for the Treatment of Vaso-Occlusive Events in Children With Severe Sickle Cell Disease
Run by Emory University · NCT02447874 · Data updated 2026-11-12
This study is testing if giving arginine to children with sickle cell disease can help reduce their pain during painful episodes and lessen their need for pain medications.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 7 Years to 21 Years |
| Sex | All |
| Enrollment | 21 (estimated) |
| Sponsor | Emory University Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Status | Recruiting |
| Started | May 2015 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT02447874 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 7-21 years with a diagnosis of sickle cell disease requiring acute pain management.
✕Probably not a fit
Patients with other types of sickle cell disease or those not requiring acute medical care may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of arginine supplementation on pain management in children with sickle cell disease experiencing vaso-occlusive events. It aims to determine if increasing arginine levels can reduce pain scores, decrease reliance on pain medications, and shorten hospital stays or emergency visits. The study includes a loading dose and continuous infusion of arginine to enhance its therapeutic effects. Participants will be monitored for pain relief and overall health outcomes during treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain management and quality of life for children with sickle cell disease.
How similar studies have gone: Previous studies have indicated that arginine may have beneficial effects in pediatric sickle cell patients, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
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
Study contacts
- Principal investigator: Claudia Morris, MD — Emory University
- Study coordinator: Reshika Mendis, MBBS
- Email: Reshika.mendis@choa.org
- Phone: 404-785-4525
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.