To determine whether addition of ipratropium bromide to salbutamol nebulisations produces significantly greater bronchodilation in young children presenting to an emergency department with an acute attack of asthma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3
Changes from baseline in pulmonary resistance (Rint) between T0 and T120
Time frame: Baseline, 120 minutes after drug administration
Assessment of accessory muscle recruitment on a 4-point scale
Time frame: Up to 120 minutes after drug administration
Assessment of wheezing on a 4-point scale
Time frame: Up to 120 minutes after drug administration
Assessment of dyspnoea on a 4-point scale
Time frame: Up to 120 minutes after drug administration
Changes in respiratory rate
Time frame: Up to 120 minutes after drug administration
Changes in Oxygen Saturation (ambient air)
Time frame: Up to 120 minutes after drug administration
Changes in measurement of pulmonary resistance
Time frame: Up to 120 minutes after drug administration
Number of patients dropped out because of lack of efficacy
Time frame: Up to 120 minutes after drug administration
Number of patients with adverse events
Time frame: Up to 17 days after last drug administration
Number of patients dropped out because of adverse events
Time frame: Up to 17 days after last drug administration
Number of patients with clinical significant findings in blood pressure
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Time frame: Up to 120 minutes after drug administration
Number of patients with clinical significant findings in heart rate
Time frame: Up to 120 minutes after drug administration
Hospital Admission rate
Time frame: 120 minutes after drug administration
Assessment of Patient Status by investigator on a 3-question list
Time frame: 72 hours after drug admimistration