Al‐Ansari 2010.
Methods | Design: randomised, double‐blind, parallel‐group, controlled trial | |
Participants | Setting: paediatric emergency facility in Qatar
Assessed for eligibility: 187
Randomised: 115 hypertonic saline group (5% saline: 57; 3% saline: 58); 56 normal saline group
Completed: 115 hypertonic saline group; 56 normal saline group
Gender (male): 59.1%
Age (mean ± SD): 3.8 ± 2.8 months in 3% saline group; 4.0 ± 2.5 months in 5% saline group; 3.3 ± 2.4 months in normal saline group Inclusion criteria: infants aged ≤ 18 months, with a prodromal history of viral upper respiratory tract infection, followed by wheezing or crackles, or both on auscultation and Wang clinical severity score ≥ 4 Exclusion criteria: born at ≤ 34 weeks’ gestation, previous history of wheezing, steroid use within 48 h of presentation, obtundation and progressive respiratory failure requiring ICU admission, history of apnoea within 24 hours before presentation, SaO₂ ≤ 85% on room air at the time of recruitment, history of a diagnosis of chronic lung disease, congenital heart disease, or immunodeficiency |
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Interventions | Intervention groups:
Group 1: nebulised 5% hypertonic saline (5 mL) plus 1.5 mL of epinephrine
Group 2: nebulised 3% hypertonic saline (5 mL) plus 1.5 mL of epinephrine Control group: nebulised 0.9% normal saline (5 mL) plus 1.5 mL of epinephrine Treatment was given every 4 hours, until the patient was ready for discharge. Nebulised medications were delivered through a tight‐fitting face mask by pressurised oxygen with the flow meter set at 10 L/min. |
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Outcomes |
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Notes | Virological identification not available | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐based randomisation program |
Allocation concealment (selection bias) | Low risk | Sequentially numbered and sealed envelopes |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 16 (9.3%) withdrawals after randomisation; baseline characteristics between treatment groups were balanced. |
Selective reporting (reporting bias) | Low risk | All predefined outcomes reported. |
Other bias | Low risk | No other bias found. |