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

Launched by EMORY UNIVERSITY · May 15, 2015

Keywords

ClinConnect Summary

This clinical trial is studying whether giving extra arginine, an amino acid, can help reduce pain in children with sickle cell disease during painful episodes, known as vaso-occlusive events. The researchers want to see if arginine can lower pain levels, reduce the need for pain medications, and shorten the time patients spend in the hospital or emergency room.

To participate in the study, children aged 7 to 21 years old who weigh at least 25 kg (about 55 lbs) and have a confirmed diagnosis of sickle cell disease (specifically Hemoglobin SS or Sβᴼ-thalassemia) are eligible. They should also be experiencing pain that requires medical treatment and the use of strong pain medications. Participants will receive arginine during their treatment, and the team will monitor their pain levels and overall care. It's important to note that there are certain conditions that would prevent a child from joining the trial, such as severe health issues or allergies to arginine. This trial aims to find new ways to help manage pain in children with sickle cell disease.

Gender

ALL

Eligibility 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