Fabio Pereira Muchão1,2, Juliana Miguita E Souza1, Hélida Conceição Cavalcante Torres1, Isabella Batista De Lalibera1, Andréa Vieira de Souza2, Joaquim Carlos Rodrigues1, Claudio Schvartsman1, Luiz Vicente Ribeiro Ferreira da Silva Filho3,4,5. 1. Instituto da Criança, Hospital das Clínicas, School of Medicine, University of São Paulo, São Paulo, Brazil. 2. Centro de Pesquisa Experimental-Instituto de Ensino e Pesquisa, Hospital Israelita Albert Einstein, São Paulo, Brazil. 3. Instituto da Criança, Hospital das Clínicas, School of Medicine, University of São Paulo, São Paulo, Brazil. vicres@terra.com.br. 4. Centro de Pesquisa Experimental-Instituto de Ensino e Pesquisa, Hospital Israelita Albert Einstein, São Paulo, Brazil. vicres@terra.com.br. 5. Laboratório de Virologia-Instituto de Medicina Tropical, University of São Paulo, São Paulo, Brazil. vicres@terra.com.br.
Abstract
BACKGROUND: The ideal dosing of albuterol via metered-dose inhalers for acute childhood asthma is not well established. We hypothesized that greater doses of albuterol would result in less time in the hospital and lower admission rates. METHODS: This was a randomized controlled double-blind multicenter study, conducted in emergency rooms (ER). We included patients with 2-17 years old with moderate to severe acute asthma (Pediatric Respiratory Assessment Measure, PRAM, score ≥5). Dosages administered during the first hour included: 6 (up to 25 kg) or 12 puffs (>25 kg) in the control group and 9 (up to 15 kg), 12 (>15-20 kg), 15 (>20-25 kg), or 18 puffs (>25 kg) in the study group. Several efficacy (changes in PRAM score, pulse oximetry, and FEV1 , length of stay, and admission rates) and safety (albuterol plasma levels, heart rate, serum potassium, glucose and bicarbonate levels, EKG, and tremor rates) outcome measures were assessed. RESULTS: We included 119 patients with similar baseline conditions, and no significant differences were observed between groups in the length of stay (P = 0.48) or admission rate (P = 0.55). No significant differences were observed in FEV1 , PRAM score, and pulse oximetry changes after 1 hr and at discharge or admission. No significant differences were observed in safety outcomes between groups. CONCLUSIONS: Higher albuterol dosage regimens did not result in lower admission rate or shorter length of stay in the ER, but showed similar safety profile for children with moderate to severe acute asthma. Pediatr Pulmonol. 2016;51:1122-1130.
RCT Entities:
BACKGROUND: The ideal dosing of albuterol via metered-dose inhalers for acute childhood asthma is not well established. We hypothesized that greater doses of albuterol would result in less time in the hospital and lower admission rates. METHODS: This was a randomized controlled double-blind multicenter study, conducted in emergency rooms (ER). We included patients with 2-17 years old with moderate to severe acute asthma (Pediatric Respiratory Assessment Measure, PRAM, score ≥5). Dosages administered during the first hour included: 6 (up to 25 kg) or 12 puffs (>25 kg) in the control group and 9 (up to 15 kg), 12 (>15-20 kg), 15 (>20-25 kg), or 18 puffs (>25 kg) in the study group. Several efficacy (changes in PRAM score, pulse oximetry, and FEV1 , length of stay, and admission rates) and safety (albuterol plasma levels, heart rate, serum potassium, glucose and bicarbonate levels, EKG, and tremor rates) outcome measures were assessed. RESULTS: We included 119 patients with similar baseline conditions, and no significant differences were observed between groups in the length of stay (P = 0.48) or admission rate (P = 0.55). No significant differences were observed in FEV1 , PRAM score, and pulse oximetry changes after 1 hr and at discharge or admission. No significant differences were observed in safety outcomes between groups. CONCLUSIONS: Higher albuterol dosage regimens did not result in lower admission rate or shorter length of stay in the ER, but showed similar safety profile for children with moderate to severe acute asthma. Pediatr Pulmonol. 2016;51:1122-1130.
Authors: Fábio Pereira Muchão; Andréa Vieira de Souza; Juliana Miguita E Souza; Luiz Vicente Ribeiro Ferreira da Silva Filho Journal: Einstein (Sao Paulo) Date: 2022-03-25