ISSN - 0973-0958

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Adverse Effects of Bronchodilators Used In Childhood Asthma - A Randomized Control Trial
Suba Guruprasad1, Mukesh Sanklecha2, Rama Yelikar3.
1Department of Pediatrics, Medeor Multispecialty Hospital, Manesar, Gurugram,
2Department of Pediatrics, Bombay Hospital Institute of Medical Sciences and Research, Marine Lines, Mumbai,
3Department of Neurology, Kokilaben Dhirubhai Ambani Hospital and Medical Research Centre..
Aim: To compare the adverse effects of the three different bronchodilators in children with a wheeze.
Design: Randomised controlled double blind study
Setting: The study was conducted in the pediatric ward of a tertiary care institution in Mumbai, India. The study was conducted from December 2011 to October 2013.
Methods: Children aged one month to 18 years admitted to the pediatric ward with wheezing were included. Children needing intensive care units, those with co-existing renal or cardiac abnormalities, intolerance to the drugs or currently on medications that lower serum potassium levels or cause tachycardia, were excluded. Out of 130 eligible patients, 40 did not give consent. Remaining 90 were randomly allocated into 3 groups in the ratio of 1:1:1 by simple randomization using a random table provided by the statistician
Intervention: Salbutamol, levosalbutamol and salbutamol + ipratropium bromide were administered to groups A, B and C respectively at intervals of twenty minutes for the first hour and then 6 hourly for the next 24 hrs. Heart rate, oxygen saturation, serum potassium levels and tremors at baseline, end of first hour and at twenty-four hours were compared in all the 3 groups.
Results: The average increase in heart rate at the end of the first hour was 11.1 + 7 beats/min in the group receiving salbutamol, 8.9 + 8 beats/min in patients receiving levosalbutamol and 8.4 + 6 beats/min in the salbutamol+ipratropium bromide group (p=0.07). At the end of 24 hours the group receiving salbutamol had an average increase in heat rate of 9.8 + 5 beats/min., 8.2 + 9 beats/min in the levosalbutamol group and 7.6 + 5 beats/min in the group receiving the combination (p=0.08). The mean baseline oxygen saturation percent were 97.7 + 1.08, 97.7 + 1.09 and 97.4 + 1.3 for the groups receiving salbutamol, levosalbutamol and salbutamol+ipratropium bromide respectively. The mean fall in the oxygen saturation in the three groups at the end of the first hour was 1.8 +1.1, 1.5+0.7 and 1.4+0.6 in the salbutamol, levosalbutmaol and salbutamol+ipratropium groups respectively (p=0.4). At the end of 24 hours the fall in saturations were 1.2 + 1.2, 0.9 + 1.1, 1.1+0.8 in the three groups respectively ( p=0.3). Fall in serum potassium levels was 0.08 + 0.5 in the group receiving salbutamol, 0.1 + 0.5 in the levosalbutamol group and 0.06 + 0.3 in the group receiving salbutamol with ipratropium bromide (p=0.4). Tremors were noted in 30% (9/30) of patients receiving only salbutamol.
Conclusion: The only adverse outcome that was significantly associated with salbutamol in our study was that of tremors. Considering the benign nature of this effect, and easy reversibility on stoppage of the drug switching to the more expensive levosalbutamol solely for this adverse effect is not justified and counseling parents regarding this potential adverse effect may be sufficient.

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