Role of intranasal midazolam as a procedural sedative in children aged 6 months to 12 years: An open-label randomized controlled study

Abstract

Objectives: The objectives of the study were to evaluate the efficacy and the adverse effects of intranasal midazolam compared to intravenous (IV) midazolam for procedural sedation in children between 6 months and 12 years of age using the University of Michigan sedation scale. Design: Prospective open-label randomized controlled trial. Setting: Children requiring sedation for any invasive or non-invasive procedure in the Department of Paediatrics, between June 2012 and May 2014. Participants: A total of 246 children aged between 6 months and 12 years of age were enrolled and sequentially allocated into the study by computer-generated block randomization. Intervention: As per randomization, participants were administered intranasal or IV midazolam before the procedure. Procedure was done 5 min after IV and 15 min after intranasal administration. Main outcome measures: Sedation score was rated using the University of Michigan Sedation Score. The ease of performance, numbers of successfully completed procedures, and adverse effects were noted. Results: Intranasal midazolam provided better sedation scores (p<0.001) and ease of procedure scores (p=0.026) compared to IV, especially in the age group from 6 months to 6 years. Both groups gave comparable successful procedure completion rates. The most commonly encountered side effect with intranasal was nasal irritation (p<0.001). Conclusion: Intranasal midazolam provided significantly better sedation and ease of procedure scores when compared to IV, with fewer adverse effects. Hence, it can be put to use in resource-limited settings.