OBJECTIVE: To compare the efficacy of salbutamol as a fixed dose Ventolin Nebule (2.5 mg) and as variable dose respirator solution (0.1 mg/kg bodyweight). DESIGN: Multicentre, randomised, double-blind, parallel group comparison. SETTING: The Emergency Departments of the Royal Children's Hospital, Melbourne, Victoria; Princess Margaret Hospital for Children, Perth, Western Australia; and The Children's Hospital, Sydney, New South Wales. PATIENTS: Ninety-nine children between four and 12 years of age who presented to the Emergency Departments with mild to moderate acute asthma from May to December 1990. INTERVENTIONS: Children enrolled in the study were randomly allocated to one of two groups. Group 1 received one Nebule (2.5 mg salbutamol in 2.5 mL aqueous solution) delivered by wet nebulisation. Group 2 received salbutamol (approximately 0.1 mg/kg bodyweight) diluted with saline to 2.5 mL, delivered by identical wet nebulisation. MAIN OUTCOME MEASURES: (i) Clinical score; (ii) pulse oximetry; and (iii) peak expiratory flow rate (PEFR) where possible--measured before, and at 15 and 30 minutes after treatment with salbutamol. RESULTS: The clinical score significantly improved in both treatment groups after 15 minutes (P < 0.001), but the difference between the two treatments (adjusted for covariates) was not significant (P = 0.97). Both preparations of salbutamol produced a significant increase in oxygen saturation after 15 minutes (P < 0.05), while the difference between the two treatments (adjusted means) was not significant (P = 0.46). Peak flow measurements were available for 65 of the 99 patients. Both preparations of salbutamol produced highly significant (P < 0.001) improvements in PEFR at 15 minutes after treatment. The difference in peak flow rates between the two treatment groups (adjusted means) was not significant (P = 0.89). The study had a power of 0.8 to detect differences between treatments of 9% PEFR (percentage predicted), 0.8% oxygen saturation and 0.77 units of clinical score. CONCLUSIONS: A fixed dose of nebulised salbutamol is as efficacious as a salbutamol dose calculated for bodyweight in children with mild to moderate acute asthma.
RCT Entities:
OBJECTIVE: To compare the efficacy of salbutamol as a fixed dose Ventolin Nebule (2.5 mg) and as variable dose respirator solution (0.1 mg/kg bodyweight). DESIGN: Multicentre, randomised, double-blind, parallel group comparison. SETTING: The Emergency Departments of the Royal Children's Hospital, Melbourne, Victoria; Princess Margaret Hospital for Children, Perth, Western Australia; and The Children's Hospital, Sydney, New South Wales. PATIENTS: Ninety-nine children between four and 12 years of age who presented to the Emergency Departments with mild to moderate acute asthma from May to December 1990. INTERVENTIONS:Children enrolled in the study were randomly allocated to one of two groups. Group 1 received one Nebule (2.5 mg salbutamol in 2.5 mL aqueous solution) delivered by wet nebulisation. Group 2 received salbutamol (approximately 0.1 mg/kg bodyweight) diluted with saline to 2.5 mL, delivered by identical wet nebulisation. MAIN OUTCOME MEASURES: (i) Clinical score; (ii) pulse oximetry; and (iii) peak expiratory flow rate (PEFR) where possible--measured before, and at 15 and 30 minutes after treatment with salbutamol. RESULTS: The clinical score significantly improved in both treatment groups after 15 minutes (P < 0.001), but the difference between the two treatments (adjusted for covariates) was not significant (P = 0.97). Both preparations of salbutamol produced a significant increase in oxygen saturation after 15 minutes (P < 0.05), while the difference between the two treatments (adjusted means) was not significant (P = 0.46). Peak flow measurements were available for 65 of the 99 patients. Both preparations of salbutamol produced highly significant (P < 0.001) improvements in PEFR at 15 minutes after treatment. The difference in peak flow rates between the two treatment groups (adjusted means) was not significant (P = 0.89). The study had a power of 0.8 to detect differences between treatments of 9% PEFR (percentage predicted), 0.8% oxygen saturation and 0.77 units of clinical score. CONCLUSIONS: A fixed dose of nebulised salbutamol is as efficacious as a salbutamol dose calculated for bodyweight in children with mild to moderate acute asthma.