Skip to main content
. 2017 Dec 21;2017(12):CD006458. doi: 10.1002/14651858.CD006458.pub4

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
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.
Outcomes
  • Wang clinical severity score

  • Oxygen saturation

  • Length of stay

  • Need for ICU admission

  • Rate of re‐admission

  • Adverse events

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.