Impact of early vs. delayed intravenous magnesium sulfate on clinical outcomes in pediatric severe asthma: a retrospective cohort study

Background: Intravenous magnesium sulfate (IV MgSO4) is a recommended second-line therapy for children with severe asthma exacerbations unresponsive to initial treatment. While its efficacy in reducing bronchospasm is supported by several studies, the optimal timing of administration in the emergency department (ED) remains unclear. This study aimed to evaluate whether early administration of IV MgSO4 (within 60 min of ED arrival) improves clinical and process outcomes in pediatric patients with severe asthma.

Methods: A retrospective cohort study was conducted at a tertiary pediatric ED in Riyadh, Saudi Arabia, including children aged 2–14 years who received IV MgSO4 for severe asthma between January 2020 and December 2024. Patients were divided into two groups based on the timing of MgSO4 administration: early ( ≤ 60 min) and late (>60 min). The primary outcome for the sample size calculation was PICU admission within 24 h. Outcomes included time to bronchodilator and corticosteroid administration, Pediatric Respiratory Assment Measure (PRAM) scores before and after treatment, changes in respiratory support, ED length of stay, hospital admission, Pediatric Intensive Care Unit (PICU) transfer, and mortality. Data were analyzed using SPSS v26.

Results: Among 233 patients, 25 (10.7%) received early IV MgSO4. The early group had significantly shorter times to bronchodilator and corticosteroid administration. Although these patients presented with higher baseline PRAM scores (greater initial severity), they demonstrated greater improvement in PRAM scores after treatment. They also had a shorter ED length of stay (p < 0.05). No significant differences were observed between groups in terms of hospital admission, PICU transfer, or mortality. Correlation analysis indicated that earlier MgSO4 use was associated with greater initial disease severity but improved early clinical response.

Conclusion: Early IV MgSO4 administration in pediatric severe asthma is associated with improved ED process measures and symptom resolution but does not significantly affect hospitalization or mortality. These findings support the feasibility and safety of early use. Larger prospective studies are needed to confirm its impact on long-term outcomes and guide clinical practice.

Introduction

Asthma is the most common chronic respiratory condition in children, contributing substantially to global morbidity and healthcare burden. According to the 2019 Global Burden of Disease analysis, asthma affected approximately 260 million individuals and was responsible for over 450,000 deaths, with nearly half of all disability-adjusted life years (DALYs) occurring before the age of 20 (1).

In Saudi Arabia, a recent nationwide Global Asthma Network survey involving over 11,000 students reported that 13–16% of children and adolescents had experienced asthma, with 5% demonstrating symptoms consistent with severe disease (2). This imposes a significant strain on healthcare resources, particularly during seasonal dust storms, which are associated with increased emergency department (ED) visits and hospital admissions (2).

The Saudi Initiative for Asthma 2024 (SINA-2024) recommends a single intravenous (IV) bolus of magnesium sulfate (25–50 mg/kg; maximum 2 g) for children who remain hypoxemic or exhibit severe airflow limitation following aggressive inhaled β₂-agonists and systemic corticosteroids (3). Magnesium's bronchodilatory and anti-inflammatory effects are mediated by inhibition of voltage-gated calcium channels in airway smooth muscle and suppression of mast cell mediator release (4).

A recent systematic review of 11 pediatric randomized controlled trials (RCTs) reported an 85% reduction in the odds of hospitalization with IV MgSO4 (pooled OR 0.15; 95% CI, 0.03–0.73), as well as improvements in peak expiratory flow, with minimal adverse events (5). However, most RCTs administered Intravenous magnesium sulfate (IV MgSO4) between 60 and 120 min after ED arrival, limiting the ability to evaluate the effect of earlier administration.

Observational data are mixed. A multicenter cohort study of 1,007 pediatric ED visits in the United States (US) found that IV MgSO4 administered within 60 min improved ED throughput but had no impact on admission rates (6). Similarly, a single-center analysis of 1,911 encounters in the US found no reduction in pediatric intensive care unit (PICU) admissions with early administration (7). Conversely, a recent tertiary cohort study of 463 patients in Canada reported that early MgSO4 recipients had shorter step-down times but higher admission rates—possibly reflecting confounding by indication (8). The IMPACT-ED pilot RCT demonstrated the feasibility of administering MgSO4 within 90 min and signaled a potential reduction in hospitalizations, though it was underpowered for outcome assessment (9).

A recent narrative review identified the optimal timing and dosing of IV MgSO4 as a critical evidence gap in pediatric asthma care, emphasizing the need for trials evaluating early administration strategies (10). Therefore, this study aimed to evaluate the impact of early vs. late IV MgSO4 administration on clinical outcomes in children with severe asthma at King Fahad Medical City (KFMC), Riyadh, Saudi Arabia.

Methods

Study design and setting

This retrospective cohort study was conducted at KFMC, a 1,200-bed tertiary care hospital in Riyadh, Saudi Arabia, between January 2020 and December 2024. KFMC's pediatric ED receives approximately 60,000 visits annually and uses the Epic electronic medical record (EMR) system (version 2019, Verona, WI).

Sample size

The primary outcome was PICU admission within 24 h. The sample size calculation compared early vs. late intravenous magnesium administration. The calculation assumed a reduction in PICU admission from 30 to 15% with 80% power and a 5% significance level. This yielded an estimated total of 212 participants; however, to account for an anticipated 10% loss due to incomplete data and to maintain statistical power under minor deviations from the assumptions, the final target sample size was set at 233 patients.

Participants and eligibility criteria

Children aged 2–14 years who presented to the ED with a severe asthma exacerbation, as defined by the Saudi Initiative for Asthma (SINA-2024) criteria—persistent oxygen saturation < 92% on room air, markedly reduced air entry or “silent chest,” or, Pediatric Respiratory Assment Measure (PRAM) score ≥8—and who received at least one intravenous (IV) dose of magnesium sulfate (MgSO4) were eligible. Exclusion criteria included pre-existing chronic lung diseases (e.g., cystic fibrosis, bronchiectasis, bronchiolitis obliterans), inter-hospital transfer more than 6 h after symptom onset, pre-hospital MgSO4 administration, and missing triage or MgSO4 time-stamps.

Case identification and exposure definition

Patient encounters were identified through the Epic Clarity database by searching for medication records indicating administration of “Magnesium sulfate in D5W 2 g/50 mL.” Cases were cross-referenced with ICD-10-CM discharge codes to exclude non-asthma diagnoses. Eligible patients were classified into two groups based on the timing of the first MgSO4 dose relative to triage time (defined as the time of the first recorded vital signs): early administration (≤60 min) and late administration (>60 min). All patients received 25–50 mg/kg (maximum 2 g over 20 min) as per the KFMC asthma protocol, which is aligned with SINA-2024 recommendations. Repeat doses did not alter exposure classification.

Data collection

Data were extracted using a standardized collection form. Variables included demographic information (age, sex, nationality), comorbidities, asthma history, clinical signs and symptoms, pre-treatment PRAM scores, initial and post-treatment vital signs and oxygen saturation, timing of bronchodilator, corticosteroid, and subcutaneous epinephrine administration, pattern of MgSO4 use, post-MgSO4 PRAM score at 1 h, changes in respiratory support, ED disposition (home, ward, PICU), need for mechanical ventilation within 24 h, hospital and PICU length of stay, return visits within 30 days, and mortality. The mean time from ED arrival to the first IV MgSO4 dose was 188.79 ± 115.81 min.

Statistical analysis

All analyses were performed using IBM Statistical Package for Social Sciences (SPSS) version 26. Categorical variables were reported as frequencies and percentages and analyzed using the Chi-squared test. Continuous variables were presented as means with standard deviations and compared using the Mann–Whitney U-test for non-parametric data. Spearman's rank correlation coefficient was used to assess associations between continuous variables. A p-value of < 0.05 was considered statistically significant.

Results

Baseline characteristics

A total of 233 children met the inclusion criteria. The mean age was 5.51 ± 2.9 years, with 53.6% aged ≤ 5 years. Females accounted for 42.5% of the cohort, and 94% were Saudi nationals. Comorbidities were reported in 37.8% of patients. Known asthma was documented in 74.2%, 68.2% were on home bronchodilators, and 51.3% were on inhaled corticosteroids. There were no statistically significant differences between the early and late MgSO4 administration groups in terms of age, gender, nationality, comorbidities, or asthma history (p > 0.05) (Table 1).

Table 1

Table 1. Comparison between early and late MgSO₄ administration according to patients' demographic characteristics, comorbidities, known asthma and asthma history (No.: 233).

Symptoms, signs, and initial management

The most common presenting symptoms were cough (90.1%), shortness of breath (82.8%), and fever (50.6%). Hypoxia (SpO₂ < 92%) was noted in 70% of patients, and 62.7% had accessory muscle use. On arrival, 54.1% of patients had a moderate PRAM score (5–8), while 14.2% had severe scores (9–12), and 1.7% had scores >12 (impending respiratory failure). Pre-hospital bronchodilator use was reported in 60.9% of cases. In the ED, 99.6% of patients received bronchodilators, 95.7% received systemic corticosteroids, and 7.7% received subcutaneous epinephrine. The most common modes of initial respiratory support were simple face mask (44.2%) and nasal cannula (28.3%). Following MgSO4 administration, 21% of patients had a downgrade in respiratory support, 20.2% experienced an upgrade, and 58.8% remained unchanged. No statistically significant differences were observed between early and late groups regarding symptoms, signs, pre-treatment PRAM score, or ED management (p > 0.05) (Tables 2, 3; Figure 1).

Table 2

Table 2. Comparison between early and late MgSO₄ administration according to symptoms, signs, and pre-treatment PRAM score (No.: 233).

Table 3

Table 3. Comparison between early and late MgSO₄ administration according to pre and post MgSO₄ administration oxygen saturation, vital signs, timing of administration of bronchodilator 1st dose, systemic steroids and SQ epinephrine at ED (No.: 233).

Figure 1

Figure 1. Comparison between early and late MgSO₄ administration according to the PRAM score (No.: 233). N.B.: (χ2 = 6.49, p-value = 0.09).

Timing of interventions and vital signs

Compared to the late group, the early MgSO4 group had significantly shorter times to bronchodilator administration (33.4 vs. 70.8 min; p < 0.001) and systemic corticosteroid administration (43.2 vs. 90.6 min; p < 0.001). No significant differences were found between the groups in triage oxygen saturation, respiratory rate, heart rate, or blood pressure. Similarly, post-treatment oxygen saturation, respiratory rate, heart rate, and duration of oxygen therapy were comparable between the two groups (Table 4).

Table 4

Table 4. Key intervention timings and treatments in early vs. late IV MgSO4 administration.

Post-MgSO4 PRAM score and respiratory support

Pre-treatment PRAM scores were recorded at triage, prior to initiation of MgSO4 or any other ED therapies, ensuring that baseline severity was not influenced by early treatment. One hour after MgSO4 administration, 58.4% of patients had a mild PRAM score (0–4), 35.2% had a moderate score (5–8), and 5.6% remained severe (9–12). Only two patients had a PRAM score >12. The most commonly used respiratory support following MgSO4 was nasal cannula (30.9%), followed by simple face mask (18.5%); one patient (0.4%) required intubation. There were no significant differences between early and late MgSO4 administration groups regarding PRAM score distribution or type of respiratory support post-treatment.

Disposition and clinical outcomes

The majority of patients (70%) were admitted to the general ward, while 23.2% required PICU admission, and 6.9% were discharged home from the ED. Two patients (0.9%) returned to the ED within 72 h, and six (2.6%) died during hospitalization. The mean ED length of stay was 11.94 ± 20.45 h, while the ward and PICU lengths of stay were 77.82 ± 95.88 h and 56.2 ± 68.6 h, respectively. Total hospital Length Of Stay (LOS) averaged 105.42 ± 139.55 h. No significant differences were noted between the early and late groups in disposition, readmission, mortality, or LOS outcomes (Table 5).

Table 5

Table 5. Comparison between early and late MgSO₄ administration according to outcome (No.: 233).

Correlation analysis

A significant positive correlation was observed between the time of MgSO4 administration and triage oxygen saturation (r = 0.33, p = 0.043), time to bronchodilator administration (r = 0.39, p < 0.001), time to systemic corticosteroid administration (r = 0.43, p < 0.001), and ED length of stay (r = 0.31, p < 0.001). In contrast, negative correlations were found between MgSO4 timing and pre-treatment PRAM score (r = −0.24, p < 0.001), post-treatment PRAM score after one hour (r = −0.17, p = 0.007), and post-treatment heart rate (r = −0.14, p = 0.032). These relationships are illustrated in Table 6 and Figures 2, 3.

Table 6

Table 6. Spearman's correlation analysis between the time of first dose of IV MgSO₄ in ED from ED arrival/minutes and pre and post MgSO₄ administration oxygen saturation, vital signs, timing of administration of bronchodilator 1st dose, systemic steroids and SQ epinephrine at ED, pre and post-treatment PRAM score and outcome (No.: 233).

Figure 2

Figure 2. Spearman's correlation analysis between the time of first dose of IV MgSO₄ in ED from ED arrival/minutes and ED length of stay/hours. N.B.: (r = 0.31, p-value = < 0.001).

Figure 3

Figure 3. Spearman's correlation analysis between the time of first dose of IV MgSO₄ in ED from ED arrival/minutes and post IV MgSO₄ PRAM score after 1 h. N.B.: (r = −0.17, p-value = 0.007).

Discussion

This retrospective cohort study evaluated the impact of early (≤60 min) vs. late (>60 min) IV MgSO4 administration in children with severe asthma. Our results show that early administration is associated with improved process outcomes—such as significantly shorter times to bronchodilator and corticosteroid initiation—and better short-term clinical improvement as reflected by pre- and post-treatment PRAM scores. However, early MgSO4 use did not significantly affect major clinical outcomes including disposition, length of stay, readmission rates, or mortality.

These findings are consistent with recent evidence. A 2024 systematic review and meta-analysis by Ambrożej et al. demonstrated that IV MgSO4 significantly reduced the odds of hospitalization in children with acute asthma (pooled OR 0.15, 95% CI: 0.03–0.73) and improved peak expiratory flow, without major safety concerns (11). However, most included studies initiated MgSO4 60–120 min after ED arrival, limiting insight into earlier use. Our study addresses this evidence gap by evaluating outcomes when MgSO4 is administered within the first hour of presentation.

Several recent large-scale observational studies have further explored this timing. Forster et al. analyzed 1,911 pediatric ED encounters and found that early IV MgSO4 was not associated with decreased PICU admission; in fact, early administration was linked with higher adjusted odds of ICU admission (OR 1.63, 95% CI: 1.16–2.28), likely due to confounding by indication (12). Similarly, Chiappetta et al. showed that children who received intensive asthma therapy—including MgSO4—had higher adjusted odds of hospitalization (aOR 25.3, 95% CI: 14.49–42.52) (8). These findings suggest that sicker patients are more likely to receive MgSO4 early, complicating interpretation of outcome data.

Despite these complexities, the physiologic rationale for early MgSO4 use is well-supported. Rower et al. demonstrated that higher serum magnesium levels achieved shortly after infusion correlate with bronchodilatory effect and respiratory improvement (13). In our study, the early group had significantly lower pre- and post-treatment PRAM scores, supporting this mechanism. Our data also revealed a significant negative correlation between time to MgSO4 and PRAM scores, indicating greater severity among early recipients—an expected pattern in real-world use. This indicates that children who received MgSO4 earlier were generally sicker at baseline, which explains their higher initial PRAM scores. Nevertheless, these patients showed more marked improvement following treatment, suggesting a benefit from earlier administration despite greater initial severity. It is important to note that patients who received early MgSO4 also received earlier bronchodilators and corticosteroids, which may have contributed to improved PRAM scores and shorter ED length of stay, representing potential confounding.

The IMPACT-ED pilot RCT supports the feasibility and safety of IV MgSO4 administration within 90 min of ED arrival and showed a trend toward reduced hospitalization, although it was underpowered to detect outcome differences (14). Similarly, a recent meta-analysis by Hamud et al. concluded that IV MgSO4 is associated with decreased hospitalization and reduced need for non-invasive ventilation, without increasing PICU admissions or serious adverse events (15).

Regionally, a national Global Asthma Network survey from Saudi Arabia reported that 13–16% of children and adolescents had experienced asthma, with 5% exhibiting symptoms of severe disease, often requiring acute interventions such as MgSO4 (16). Alrasheed et al. also demonstrated inconsistent adoption of MgSO4 across pediatric EDs in the Gulf region, with variations in timing, dose, and escalation thresholds (17). The Saudi Initiative for Asthma (SINA-2024) recommends MgSO4 for children with persistent hypoxemia or severe airflow limitation following first-line treatment, supporting its early use in refractory cases (3).

Despite strong process improvements with early MgSO4, our study did not observe reductions in hospitalization or PICU admission rates. This mirrors findings from other large cohorts and may reflect clinical practice patterns, provider bias, or institutional thresholds for admission. Furthermore, many centers still use MgSO4 as a late “rescue” therapy rather than a proactive adjunct, despite mounting evidence favoring earlier use (18–20).

Nonetheless, this study adds valuable local data to the global literature. It reinforces that early IV MgSO4 administration is safe, feasible, and associated with modest short-term clinical benefit, particularly in terms of symptom resolution and ED flow metrics. Future multicenter, prospective, randomized studies are needed to confirm whether early MgSO4 use translates into reduced escalation of care, shorter hospitalizations, and improved long-term outcomes.

Limitations

Although this study provides valuable insights, several limitations must be acknowledged. First, the retrospective design restricts causal inference and introduces the possibility of residual confounding. While we controlled for baseline characteristics, we could not adjust for unmeasured factors such as asthma severity prior to ED arrival, prehospital treatments, or provider decision-making variability. Second, documentation variability and reliance on electronic time stamps may have introduced inaccuracies in defining “early” vs. “late” MgSO4 administration. Third, the early MgSO4 group constituted a relatively small portion of the cohort (n = 25), which may have limited the power to detect significant differences in outcomes such as PICU admission or mortality. Additionally, this was a single-center study, which may limit generalizability. Finally, the study focused exclusively on short-term ED and inpatient outcomes without evaluating long-term asthma control, quality of life, or functional recovery. Although seasonal dust storms are known to increase pediatric asthma ED visits and severity, seasonality was not specifically analyzed in this study. Future research should explore seasonal effects on presentation severity and outcomes. A formal sub-analysis comparing outcomes between patients who received 25 vs. 50 mg/kg was not performed due to the small number receiving the lower dose. Future prospective studies should examine potential dose–response effects.

Conclusion

In this single-center cohort study, early administration of intravenous magnesium sulfate (within 60 min of ED arrival) in children with severe asthma was associated with improved process indicators, including faster initiation of bronchodilators and corticosteroids, and modest improvements in PRAM scores and ED length of stay. However, early administration did not significantly impact hospitalization rates, PICU admissions, or mortality. These findings suggest that early MgSO4 use is feasible, safe, and may enhance initial stabilization without increasing adverse outcomes. Given the growing body of evidence supporting early intervention, future multicenter randomized controlled trials are warranted to confirm these findings, identify optimal timing and dosing strategies, and evaluate patient-centered and long-term outcomes.

Data availability statement

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.

Ethics statement

The studies involving humans were approved by King Fahad Medical City Institutional Review Board. The studies were conducted in accordance with the local legislation and institutional requirements. Written informed consent for participation in this study was provided by the participants' legal guardians/next of kin.

Author contributions

MA: Conceptualization, Data curation, Formal analysis, Investigation, Resources, Visualization, Writing – original draft. SAl: Conceptualization, Data curation, Methodology, Supervision, Writing – original draft. RAlo: Formal analysis, Methodology, Project administration, Supervision, Validation, Writing – original draft. IA: Conceptualization, Investigation, Writing – original draft. NA: Data curation, Methodology, Writing – original draft. RAlm: Formal analysis, Project administration, Writing – original draft. SAb: Conceptualization, Writing – original draft. HA: Methodology, Writing – original draft. RAlr: Data curation, Methodology, Supervision, Writing – original draft, Writing – review & editing. YA: Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Resources, Software, Supervision, Validation, Visualization, Writing – original draft, Writing – review & editing.

Funding

The author(s) declare that no financial support was received for the research and/or publication of this article.

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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