Intravenous L-Citrulline for Vaso-occlusive Pain Episode in Sickle Cell Disease
About this study
The goal of this clinical trial is to learn if intravenous citrulline works to treat acute pain in hospitalized patients with sickle cell disease. It will also learn about the safety of intravenous citrulline. The main questions it aims to answer are: * Does intravenous citrulline decrease the duration of sickle cell pain during hospitalization * What medical problems do participants have when taking intravenous citrulline? Researchers will compare intravenous citrulline to a placebo (a look-alike substance that contains no drug) to see if intravenous citrulline works to treat acute pain. Participants will: * Receive baseline tests and intravenous citrulline for 16 hours during the hospital stay * After hospital discharge, visit the clinic in about 30 days for checkup and tests
- Condition
- Sickle Cell Disease, Vaso-occlusive Pain Episode
- Tested
- L-citrulline, Placebo, L-citrulline
- Sponsor
- Suvankar Majumdar
Who can join
- Age
- 4 to 21 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 4 years
- Maximum age: 21 years
- Study condition: Sickle Cell Disease, Vaso-occlusive Pain Episode
- Sickle cell disease (all genotypes)
- Patients with sickle cell disease ages 4 to 21 years old
- Presence of sickle cell vaso-occlusive pain episode requiring hospitalization and parenteral opioid therapy
- Able to randomize to study drug/placebo within 12 hours of first dose of parenteral opioid in the Emergency Department
Exclusion 14
- Current pain lasting \>3 days.
- \>9 hospitalizations in the prior year
- Presence of any other complication related to sickle cell disease requiring the hospitalization such as splenic sequestration, hepatic sequestration, stroke, transient ischemic attack, etc.
- History of opioid use disorder, chronic pain or medical regimen requiring daily opioid use.
- Severe anemia (hemoglobin \<6g/dL)
- Pregnant (as confirmed by a positive urine pregnancy test) or lactating female.
- Alanine/aspartate transferase \>2x upper limit of normal laboratory range for age.
- Subject has the following serum creatinine:
- Age 4 to 13 years \> 0.9 mg/dL
- Age 14 to 17 years 1.0 mg/dL
- Age ≥18 years \>1.5mg/dL
- Presence of acute chest syndrome, sepsis, bacterial infection, hemodynamic instability
- Use of L-glutamine
- History of allergic reaction to L-citrulline products
Where
1 site, 1 recruiting
Children's National Hospital
Washington D.C., District of Columbia, United States
Contact
-
Jillian Baker, RN
202-476-1311 jbaker5@childrensnational.org
Potential match only. Final eligibility is determined by the study team.