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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborators: Children's Healthcare of Atlanta; National Center for Complementary and Integrative Health (NCCIH)

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

• Hepatic dysfunction: serum glutamic pyruvic transaminase (SGPT) > 3X upper value

• 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

• Previous randomization in this arginine pK study (patient consented and screened failed before receiving study drug or placebo remains eligible for future participation)

• Use of inhaled nitric oxide, sildenafil or arginine within the last month