Randomized control trial of oral arginine therapy for children with sickle cell anemia hospitalized for pain in Nigeria

Low arginine bioavailability is associated with vaso‐occlusive painful crisis (VOC) severity in sickle cell anemia (SCA) and predicts need for pediatric hospitalization. Intravenous arginine therapy has opioid‐sparing effects and was found to significantly decrease pain scores in children hospitaliz...

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Bibliographic Details
Published in:American journal of hematology 2021-01, Vol.96 (1), p.89-97
Main Authors: Onalo, Richard, Cooper, Peter, Cilliers, Antoinette, Vorster, Barend C., Uche, Nnebe‐Agumadu, Oluseyi, Oniyangi O., Onalo, Victoria D., Zubairu, Yunusa, Ayodele‐Kehinde, Alice U., Damilare, Oladimeji M., Figueroa, Janet, Morris, Claudia R.
Format: Article
Language:English
Subjects:
Acute Chest Syndrome - drug therapy
Acute Chest Syndrome - economics
Administration, Oral
Adolescent
Analgesics
Anemia
Arginine
Arginine - administration & dosage
Arginine - economics
Bioavailability
Child
Child, Preschool
Children
Double-Blind Method
Female
Hematology
Hospitalization
Humans
Intravenous administration
Length of Stay
Male
Nigeria
Opioids
Pain
Patients
Prospective Studies
Sickle cell anemia
Sickle cell disease
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Summary:Low arginine bioavailability is associated with vaso‐occlusive painful crisis (VOC) severity in sickle cell anemia (SCA) and predicts need for pediatric hospitalization. Intravenous arginine therapy has opioid‐sparing effects and was found to significantly decrease pain scores in children hospitalized with SCA‐VOC in a phase‐two randomized placebo‐controlled trial (RCT). Efficacy of oral arginine is unknown. Our objective was to determine the safety and efficacy of oral arginine therapy in Nigerian children with SCA. A double‐blind RCT of oral L‐arginine‐hydrochloride (100 mg/kg TID) was conducted in children with SCA‐VOC, aged 5‐17 years, hospitalized at two Nigerian sites. The primary outcome measure was analgesic usage, quantified by difference in the mean Analgesic Medication Quantification Scale (MQS). Secondary outcomes included daily pain scores, time‐to‐crisis‐resolution and length‐of‐hospital‐stay. An intention‐to‐treat analysis was performed. Sixty‐eight children (age 5‐17 years, mean 10.6 ± 0.4 years; 56% male), were randomized to receive L‐arginine (35 patients) or placebo (33 patients). The mean total MQS for the arginine group was 73.4 (95% CI, 62.4‐84.3) vs 120.0 (96.7‐143.3) for placebo (P 
ISSN:0361-8609
1096-8652
DOI:10.1002/ajh.26028