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. 2017 Dec 21;2017(12):CD006458. doi: 10.1002/14651858.CD006458.pub4

Grewal 2009.

Methods Design: randomised, double‐blind, parallel‐group, controlled trial
Participants Setting: emergency department of a children's hospital in Canada
 Assessed for eligibility: not stated
 Randomised: 24 hypertonic saline group; 24 normal saline group
 Completed: 23 hypertonic saline group; 23 normal saline group
 Gender (male): 60.9%
 Age (mean ± SD): 5.6 ± 4.0 months in hypertonic saline group; 4.4 ± 3.4 months in normal saline group
Inclusion criteria: infants aged 6 weeks to 12 months presenting with a first episode of wheezing and clinical symptoms of a viral respiratory infection, plus an initial SaO₂ of 85% or more but 96% or less, and RDAI score ≥ 4
Exclusion criteria: pre‐existing cardiac or pulmonary disease, previous diagnosis of asthma by a physician, any previous use of bronchodilators (except for treatment of the current illness), severe disease requiring resuscitation room care, inability to take medication using a nebuliser, inability to obtain informed consent secondary to a language barrier, or no phone access for follow‐up
Interventions Intervention group: nebulised 3% hypertonic saline (2.5 mL) plus 0.5 mL 2.25% racaemic epinephrine
 Control group: nebulised 0.9% normal saline (2.5 mL) plus 0.5 mL 2.25% racaemic epinephrine
 Both groups received inhalation solutions at 0 minutes.
Each treatment was given by nebuliser with continuous flow of oxygen at 6 L/min. 2 doses of the study drug were available for each infant such that, if the physician felt that a second dose of racaemic epinephrine was needed during the 120‐minute study period, the infant received the same drug combination again.
Outcomes
  • Respiratory assessment change score

  • Oxygen saturation

  • Rate of hospitalisation

  • Rate of re‐admission

  • Adverse events

Notes RSV positive: 82.6% in hypertonic saline group; 81.8% in normal saline group
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Website randomisation scheme
Allocation concealment (selection bias) Low risk The solutions prepared by the hospital pharmacy were similar in appearance and smell, stored in identical syringes, labelled only by a code number, and placed in the research cupboard within the emergency department.
Blinding (performance bias and detection bias) 
 All outcomes Low risk Double‐blind
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 2 (4.1%) withdrawals (1 hypertonic saline group; 1 normal saline group)
Selective reporting (reporting bias) Low risk All predefined outcomes reported.
Other bias Low risk No other bias found.