Actively Recruiting
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
Led by Emory University · Updated on 2025-07-11
21
Participants Needed
2
Research Sites
582 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
C
Children's Healthcare of Atlanta
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of sickle cell disease--Hemoglobin SS (Hb-SS) or Sβ0-thalassemia
- Age between 7 and 21 years
- Weight 25 kg (55 lbs) or more
- Pain requiring medical care in an acute care setting needing parenteral opioids, not due to other causes
You will not qualify if you...
- Decision to discharge home from acute care setting
- Diagnosis of sickle cell disease types other than Hb-SS or Sβ0-thalassemia (including HbSC, Hb-Beta Thal, HbSD, HbSE, HbSO, Hb AS carrier)
- Hemoglobin less than 5 gm/dL
- Immediate red cell transfusion anticipated
- Renal dysfunction with creatinine greater than 1.0 or twice baseline
- Mental status or neurological changes
- Acute stroke or clinical concern for stroke
- Pregnancy
- Allergy to arginine
- Previous hospitalization within the last 7 days
- Use of inhaled nitric oxide, sildenafil, or arginine within the last 14 days
- Not an appropriate candidate as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Children's Healthcare fo Atlanta at Hughes Spalding
Atlanta, Georgia, United States, 30303
Actively Recruiting
2
Children's Healthcare of Atlanta at Arthur M. Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
Research Team
R
Reshika Mendis, MBBS
CONTACT
C
Claudia Morris, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
6
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here