Background and objective: Vaso-occlusive episodes (VOEs) are the most common complication of sickle cell disease in children. Treatment with magnesium seems to improve cellular hydration and may result in reduced vaso-occlusion. This study aimed to determine if intravenous (IV) magnesium sulfate (MgSO4) reduces length of stay (LOS) in hospital, pain scores, and cumulative analgesia when compared with placebo.
Methods: Randomized, double-blind, placebo-controlled trial in children aged 4 to 18 years requiring admission to hospital with a sickle cell disease VOE requiring IV analgesia. Participating children received IV MgSO4 (100 mg/kg) every 8 hours or placebo in addition to standard therapy. We used a t test or Mann-Whitney test (continuous variables), Fisher's exact test, or χ2 test (frequencies). P values were considered significant if <.05, and 95% confidence intervals were calculated for the difference between groups.
Results: One hundred six children were randomly assigned to the study, and 104 were included. Fifty-one (49%) received MgSO4. Children's mean age was 12.4 years (range: 4-18 years; SD: 3.8 years), and 56 (54%) were females. There was no significant difference in the primary outcome measure, LOS in hospital, with a mean of 132.6 and 117.7 hours in the MgSO4 and placebo groups, respectively (P = .41). There was no significant difference between groups for the secondary outcomes of mean pain scores (4.9 ± 2.6 vs 4.8 ± 2.6, respectively; P = .92) or analgesic requirements (continuous morphine infusion [P = .928], boluses of IV morphine [P = .82], acetaminophen [P = .34], ibuprofen [P = .15], naproxen [P = .10]). Only minor adverse events were recorded in both groups. Pain at the infusion site was more common in the MgSO4 group.
Conclusions: IV MgSO4 was well tolerated but had no effect on the LOS in hospital, pain scores, or cumulative analgesia use in admitted children with a VOE.
Trial registration: ClinicalTrials.gov NCT00313963.
Keywords: admission; children; magnesium; pain; sickle cell disease; vaso-occlusive episode.