Ali Kumble, Abhishek K Phadke, Arun Varghese, Poonam Raikar, Kaushal Patel, Shuhada Arif Khan.
Indiana Hospital and Heart Institute, Mangaluru, Karnataka, India.
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Abstract
Background: Midazolam is the most widely used agent in procedural sedation. The objective of the study was to compare the efficacy of midazolam administered via intranasal and intravenous route among pediatric patients.
Methods: An open-labeled randomized controlled trial was conducted in a tertiary care hospital. Children between six months and 10 years requiring sedation for investigative procedures (both invasive and noninvasive) were randomly assigned to either intranasal group (0.2 mg/kg body weight) or via intravenous group (0.1 mg/kg body weight). The main outcomes measured were mean time taken for sedation, level and adequacy of sedation and ease of doing procedure between the two groups. The secondary outcome measures included the number of doses required, procedure completion rate and the total number of adverse events between the two groups respectively.
Results: 44 patients (22 in each group) were enrolled over a 9-month study period. Mean time (in minutes) taken for satisfactory sedation by intravenous route was 5.5 ± 2.31 as compared to 10.29 ± 1.72 in intranasal route (P = 0.001). The frequency of oxygen desaturation was more in intravenous group as compared to intranasal group. The rest of the measured variables were similar in both the groups with no statistical difference between the groups.
Conclusion: Midazolam administered via intravenous route had shorter mean time of sedation albeit with more adverse events than intranasal route. If time taken for intravenous administration is added, intranasal route is easier and faster. Both the routes were comparable.
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