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Efficacy and safety of a home-made non-valved spacer for bronchodilator therapy in acute asthma
Duarte M, Camargos P
Acta Paediatrica 2002;91(9):909-913
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

The aim of this study was to assess the efficacy and safety of an alternative spacer to deliver salbutamol in acute asthma. A prospective randomized study was performed with 196 patients with acute asthma, aged 4 to 15 y. The clinical features, oxygen saturation (SaO2) and the best of three peak expiratory flow rate (PEFR) measurements were recorded in a standardized questionnaire. Each patient received up to three conventional doses of salbutamol through an alternative home-made non-valved spacer (NVS) (500 ml mineral water plastic bottle) or an oxygen-driven nebulizer (ODN). The clinical and functional respiratory parameters (PEFR and SaO2) were assessed 15 min after each administration of the bronchodilator. In the ODN (n = 99) and NVS (n = 97) groups, PEFR (p > 0.05) and SaO2 (p > 0.05) measurements improved in all stages of the treatment. During the asthma attacks, the ODN group needed a prolonged observation in the emergency room (p = 0.000000). Side effects of salbutamol, eg, increased heart rate, were observed in 17.2% of the patients in the ODN group and 4.1% in the NVS group (p = 0.003). CONCLUSION: Both devices showed comparable efficacy in mild and moderate acute attacks, but the use of the alternative NVS resulted in a shorter observation period in the emergency room. The frequency of side effects was significantly higher in the ODN group than in the NVS group.

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