Vaso-occlusive Pain Episodes
Conditions
Keywords
sickle cell disease, vaso-occlusive pain episodes, arginine, nitric oxide
Brief summary
Vaso-occlusion contributes significantly to morbidity in sickle cell disease (SCD). Vaso-occlusive painful episodes (VOE) are common and debilitating, causing the majority of emergency department visits. Currently efforts to treat painful episodes with use of non-steroidal pain relievers and intravenous narcotics offer symptomatic relief only, without targeting the underlying mechanisms of vaso-occlusion.Investigators have found that an arginine deficiency and low NO bioavailability occurs during painful events in SCD. Since arginine is the obligate substrate for NO production, and an acute deficiency is associated with VOE, investigators hypothesized that arginine supplementation may be a safe and beneficial treatment for sickle cell pain.
Interventions
DRUGArginine
DRUGPlacebo
Saline or Sugar pill was given as placebo
Sponsors
UCSF Benioff Children's Hospital Oakland
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Established Diagnosis of Sickle Cell Disease(SS,SC,S-beta thal) * Admitted to Hospital for pain * Pain requiring hospitalization for parenteral narcotics, not attributable to non-sickle cell causes * \>3 year and older
Exclusion criteria
* Hemoglobin less than 5gm/dL or immediate need for red cell transfusion * Hepatic Dysfunction: increased in SGPT to \>2x normal value * Renal Dysfunction: increased in creatinine to \>2x normal value or \>1.5 * Mental status or neurological changes * Pregnancy * \>10 Hospitalizations per year or history of dependance to narcotics * Inability to take oral medications or allergy to arginine * Inability to use a PCA device * \< 3 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of Hospital Stay | participants will be followed for the duration of hospital stay an expected average of 3-6 days, with re-admission data being collect for up to 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Effect on Pain Score | participants will be followed for the duration of hospital stay an expected average of 3-6 days |
| Total Opioid Use (mg/kg) | participants will be followed for the duration of hospital stay an expected average of 3-6 days |
Countries
United States
Outcome results
None listed