Intranasal midazolam sedation as an effective sedation route in pediatric patients for radiologic imaging in the emergency ward: A single-blind randomized trial
Masoud Mayel1(0000‐0002‐8777‐3991), Mehdi Ahmadi Nejad2(0000‐0002‐3837‐752X), Mehdi Sadeghi Khabaz1(0000‐0003‐2425‐3443), Maliheh Sadat Bazrafshani3(0000‐0001‐6170‐8713), Ehsan Mohajeri4(0000‐0003‐2996‐0630)
1Department of Emergency Medicine, Faculty of Medicine, Kerman University of Medical Sciences, Kerman, Iran
2Department of Anesthesiology, Faculty of Medicine, Kerman University of Medical Sciences, Kerman, Iran
3Student Research Committee, Kerman University of Medical Sciences, Kerman, Iran
4Department of Pharmaceutics, Faculty of Pharmacy, Kerman University of Medical Sciences, Kerman, Iran
Keywords: Emergency ward, intranasal, midazolam, radiologic imaging
OBJECTIVES: Prevention and reduction of pain, anxiety, and fear during medical procedures is one of the most important factors that should be considered in pediatric emergencies. The aim of this study was to compare the efficacy of oral versus intranasal midazolam in sedation during radiologic imaging in the largest province of Iran, Kerman.
MATERIALS AND METHODS: Eighty children were enrolled in this single-blind clinical trial based on convenience sampling and were divided into two groups receiving 0.5 mg/kg midazolam in oral route administration and 0.2 mg/kg midazolam in intranasal route administration. Finally, 75 patients remained for evaluating medication acceptability, sedation level, onset time of sedation, additional sedative dose, adverse effects of sedation, and provider satisfaction.
RESULTS: Children in the intranasal group accepted medication more easily (89.8% vs. 36.9%; P≤ 0.001), while these children received a lower sedation dose, but the sedation level in both methods was similar (P = 0.72). Our findings showed that children in the intranasal sedation group had a faster onset of sedation compared to the oral group (17.94 ± 8.99 vs. 34.50 ± 11.45; P≤ 0.001). The frequency of midazolam side effects had no difference between the groups (29.7% vs. 15.8%; P = 0.15).
CONCLUSION: Intranasal midazolam with a lower sedation dose induces a faster onset and better acceptance. Intranasal midazolam can be used as an effective sedative method for pediatric patients, especially in emergency wards.
This study was approved by the Ethics Committee of Kerman University of Medical Sciences (Code number: 96000190).
All patients consented to participate to the study. Signed consent forms available from the authors.
All authors contributed toward data analysis, drafting, and revising the paper and agree to be accountable for all aspects of the work (conception – Masoud Mayel and Ehsan Mohajeri, design – Masoud Mayel, Mehdi Ahmadinejad, and Mehdi Sadeghi Khabaz, and analysis and interpretation of data – Maliheh Sadat Bazrafshani).
We would like to express our sincere thanks to all nurses of radiology and emergency wards of Shahid Bahonar Hospital (Kerman, Iran) who helped us in conducting this research.