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 |
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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. |
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Outcomes |
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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. |