EFFECT OF ADDITION OF SINGLE DOSE OF ORAL MONTELUKAST TO STANDARD THERAPY IN ACUTE MODERATE ASTHMA IN CHILDREN 5 to 12 YEARS OF AGE: A RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED TRIAL

Abstract

SESSION TITLE: Wednesday Abstract Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/23/2019 09:45 AM - 10:45 AM PURPOSE: To study the effect of addition of single dose of oral montelukast to standard therapy in acute moderate exacerbations of asthma in children 5 – 12 years of age METHODS: Design- Randomised, double blind,placebo controlled trial Study population – All children aged 5-12 yrs presenting with acute exacerbation of asthma with a Pulmonary Scoring Index (PSI) of 4 – 6 and a past history of at least 3 episodes of cough and wheezing, responding to bronchodilators,in the out patient and emergency department of Government T D Medical College,Alleppey,Kerala,S.India during a period of one year from 1st August 2012 . Exclusion Criteria – Children unable to take oral medication Those who received Montelukast during previous 1 week Those with other underlying cardio- respiratory illnesses or suspected pneumonia. Those whose parents not consenting for participation in the study. Procedure – All the enrolled subjects received the standard therapy as per guidelines of American Academy of Asthma & Allergy and AAP.They were randomnly assigned to two groups. Group A received single tablet of montelukast(5mg) and GroupB received a placebo tablet.Both medicines were coded and decoding was done only before final analysis.Patients were reassessed at 4hours for reduction in PSI score.The data collected were analysed using Wilcoxon signed rank test and Man Whitney test. RESULTS: Results- 43 patients were enrolled with 29 receiving Montelukast(Gp A) and 14 placebo(Gp B).With a drop out of 2 from Gp A,final number was 41(27 vs 14).The two groups were comparable regarding age,sex and mean PSI at 0 hours.The mean of fall inPSI score (i.e improvement) in the two groups were 3.08 (SD-0.781) and 2.71 (SD- 0.825) respectively which was not statistically significant(P=0.167). CONCLUSIONS: There is no added advantage of using oral montelukast to standard therapy in acute moderate exacerbation of asthma. CLINICAL IMPLICATIONS: Montelukast cannot be an adjuant in treatment of acute moderate exacerbations of asthma DISCLOSURES: no disclosure on file for Anoop Cherungonath; No relevant relationships by Girija Mohan, source=Web Response No relevant relationships by SREELATHA VENUGOPAL, source=Web Response