Alansari 2015.
Methods | Double‐blind, randomised controlled trial. 1 Paediatric emergency centre, Qatar. |
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Participants | Inclusion criteria: moderate/severe asthma exacerbation, age 2‐14 years, previous diagnosis of asthma. Exclusion criteria: prematurity, critical illness needing ICU admission for IV bronchodilator, NIV or invasive ventilation, transfer to other institution, history of hypersensitivity to MgSO₄, history of neuromuscular/cardiac/renal disease, underlying structural lung disease, received systemic steroid/theophylline/ipratropium in prior 72 h, consolidation on chest XR, received IV MgSO₄ before randomisation, prior participation in the study, haemodynamic instability. Number randomised: 400. Intervention: 208 randomised. Mean age (years): 5.6 (3.1). Male:female: 133:75. Moderate:severe: 168:40. Mean baseline asthma severity score: 7.6 (1.3). Control: 192 randomised. Mean age (years): 5.8 (3.1). Male:female: 115:77. Moderate:severe: 163:29. Mean baseline asthma severity score: 7.5 (1.3). |
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Interventions | Intervention: 800 mg MgSO₄ (15 mL). Control: 15 mL 0.9% NaCl. Medication divided into 3 doses over 1 h. Jet nebuliser. |
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Outcomes | Time to medical readiness for discharge, mean asthma severity score (4, 8, 12, 24, 36, 48 h), mean asthma severity score at discharge, need for revisit or readmission (2 weeks). Adverse events: chest tightness and facial rash (1; intervention group). Excessive cough (1; control group). ICU admission (1; control group). |
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Notes | Funding: Hamad Medical Corporation; Number: 12095/12 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation without blocks. |
Allocation concealment (selection bias) | Low risk | Randomisation list provided to pharmacy resulted in preparation of identical‐appearing sealed numbered vials. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | All study personnel were blinded to treatment. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All study personnel were blinded to treatment. The paper was not explicit re. outcome assessors ‒ they were assumed to also have been blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Over 90% completed the trial in both arms. Balanced number were excluded from each arm, with reasons given. |
Selective reporting (reporting bias) | Low risk | Prospective trial registration. All listed outcomes are reported. |