Efficacy and safety of intranasal midazolam versus chloral hydrate as sedation for quality computed tomography imaging in children

INTRODUCTION: The purpose of this study was to compare the efficacy and safety of aerosolized intranasal midazolam to oral chloral hydrate as procedural sedatives in pediatric patients undergoing CT imaging.
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 scheduled to undergo the brain CT scan.
One hundred sixty children were randomized to receive intranasal midazolam (INM) 0.3 mg/kg with oral placebo or 75 mg/kg oral chloral hydrate (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 Ramsay sedation scale (RSS)

RESULTS: Both groups were comparable with respect to age, male to female ratio, weight, and baseline vital signs. 62 children (77.50%) in INM group and 59 children (73.42%) in OCH groups reached 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 study groups (p=0.836). The majority of parents were somewhat to very satisfied, 83.54% and 81.25% in OCH and INM groups, respectively (p=0.928).
DISCUSSION AND CONCLUSION: Intranasal midazolam can be used to sedate the children at age group between 1 to 8 years who undergo computed tomography imaging of brain with the comparable rate of efficacy and safety as oral chloral hydrate.