Hossein 2016.
Methods | Double blind, randomised controlled trial. 2 emergency departments, Iran. |
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Participants | Inclusion criteria: moderate/severe asthma exacerbation defined by PEFR < 40% to 69% predicted or limiting speech/normal activity, age > 16 years. Exclusion criteria: need for immediate intubation, significant impairment of heart function, kidney or liver disease, fever > 38.3 °C, chronic lung disease, pregnancy, lactation, pneumonia. 50 randomised. Intervention: 25 randomised. Mean age (years): 52.4 (16.9). Men:women: 11:14. Acute moderate: 3. Acute severe: 22. Mean predicted PEF (%): 15.1 (4.7). Control: 25 randomised. Mean age (years): 53.9 (16.2). Men:women: 14:11. Acute moderate: 3. Acute severe: 21 Mean predicted PEF (%): 14.7 (6.4). |
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Interventions | Intervention: 3 mL MgSO₄ solution (260 mmol/L) nebulised. Control: 3 mL 0.9% NaCl nebulised. Nebulised medication given every 20 to 60 minutes. |
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Outcomes | Predicted PEFR (%), oxygen saturations, respiratory rate, dyspnoea severity index (20, 60 minutes); need for admission, serious side‐effect rate (60 minutes). Adverse effects: no "serious side‐effects" reported. |
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Notes | Funding: not reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation software used. |
Allocation concealment (selection bias) | Unclear risk | Data not given. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both patients and investigators were blinded to the content of identical treatment vials. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Both patients and investigators were blinded to the content of identical treatment vials. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The report does not state that all 25 randomised participants in each arm completed the trial, but as the trial finished at 60 mins is it likely that they did. |
Selective reporting (reporting bias) | Unclear risk | Trial registered while recruiting. Pre‐specified primary and secondary outcomes are reported; note omission of PEFR/dyspnoea scale reporting at 40 mins and no data given to support report of "no treatment‐related complications". Clear mistakes in reporting of vital signs. |