Efficacy and Safety of Intranasal Midazolam Versus Chloral Hydrate as Sedation for Quality Computed Tomography Imaging in Children

Abstract

The purpose of this study was to compare the efficacy and safety of aerosolized intranasal midazolam (INM) compared to oral chloral hydrate (OCH) as procedural sedatives in pediatric patients undergoing computed tomography (CT) imaging. Materials and Methods: A prospective, randomized, double-blind clinical trial was utilized in children aged 1 to 8 years who presented to the ED with minor head trauma and were scheduled to undergo brain CT scan. One hundred and sixty children were randomized to receive INM 0.3 mg/kg with oral placebo or 75 mg/kg OCH with intranasal placebo. If the patient was not adequately sedated 20 minutes after the initial dose, a second dose of the same medication at one-third of the initial dosage was given. The sedation level of patients after drug administration was assessed using the Ramsay sedation scale. Results: Both groups were comparable with respect to age, male to female ratio, weight, and baseline vital signs. Sixty two children (77.50%) in the INM group and 59 children (73.42%) in the OCH groups reached a Ramsay score of four, respectively (p=0.55). There was no significant difference in regards to the time to become adequately sedated (21.32±6.54 vs 23.62±7.40, p=0.173) and time for completing CT scan (30.37±7.18 vs 32.96±7.85, p=0.185). However, the time to recovery was shorter for the INM group (72.52±10.17 vs 88.10±10.27, p=0.001). No serious side effects were seen in the study groups (p=0.836). The majority of parents were somewhat to very satisfied, 83.54% and 81.25% in the OCH and INM groups, respectively (p=0.928). Conclusion: INM can be used to sedate children between 1 to 8 years who are to undergo CT imaging of brain with a comparable rate of efficacy and safety to OCH.