| Methods |
Design: Parallel group study (four arms). Randomisation: block randomisation. Blinding: single blind. Excluded: described. Withdrawals: none. Baseline characteristics: comparable. Power calculation: 22 for each spacer to ensure detection of a 15% change in PEFR at a significance level of 0.05 with a power of 90% for each type of spacer. Modified Jadad score: 3 |
| Participants |
Setting: South Africa. Red Cross Children´s Hospital. 88 children (22 in each arm) aged 5 to 13 years. Inclusion criteria: children with a known history of asthma who presented to the Hospital with an acute asthma attack. Exclusion criteria: inability to use an MDI and spacer or to reliably undergo pulmonary function tests, PEFR < 20% of the predicted normal, arterial oxygen saturation < 92% in air, underlying cardiac or other chronic chronic pulmonary disease, treatment with oral corticosteroids for more than 5 days before presentation, and use of beta‐agonists within 4hours of presentation. |
| Interventions |
Beta‐agonist: fenoterol hydrobromide. Home‐made spacers: sealed 500 ml plastic cold‐drink bottle, unsealed 500 ml plastic cold‐drink bottle, and 200 ml polystyrene cup. Dosage: 4 puffs (400 µg) for children who weighed 25 kg or less, and 6 puffs (600 µg) for children who weighed more than 25 kg, given at a rate of 1 puff every 10 seconds. Co‐interventions: fenoterol 1000 µg in 2 ml normal saline via a jet nebuliser, and oxygen at a flow rate of 5 L per min in children who after bronchodilator treatment had PEFR < 70% of the predicted value.
Beta‐agonist: fenoterol hydrobromide. Commercial spacer: Aerochamber 145 ml. Dosage: 4 puffs (400 µg) for children who weighed 25 kg or less, and 6 puffs (600 µg) for children who weighed more than 25 kg, given at a rate of 1 puff every 10 seconds.
Co‐interventions: fenoterol 1000 µg in 2 ml normal saline via a jet nebuliser, and oxygen at a flow rate of 5 L per min in children who after bronchodilator treatment had PEFR < 70% of the predicted value. |
| Outcomes |
Primary outcomes: changes in clinical score and pulmonary function, and need for and response to nebulisation. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Method to generate randomised sequence not reported; investigators employed block randomisation. |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported |
