Evaluation of intranasal Midazolam spray as a sedative in pediatric patients for radiological imaging procedures

Abstract

Context:Preoperative anxiety and uncooperativeness experienced by pediatric patients are commonly associated with postoperative behavioral problems.Aims:We aimed to evaluate the efficacy and safety of intranasal Midazolam as a sedative in a pediatric age group for radiological imaging procedures and to note onset of sedation, level of sedation, condition of patient during separation from parents and effect on the cardio-respiratory system.Settings and Design:Randomized double-blinded study.Subjects and Methods:Fifty patients of the pediatric age group of American Society of Anesthesiologist grade 2 and 3 who came for any radiological imaging procedures were studied. Patients were randomly allocated to receive, intranasally, either Midazolam 0.5 mg/kg (group A N = 25) or normal saline (group B N = 25) in both nostrils (0.25 mg/kg in each) 15 min before the procedure. Time for onset of sedation and satisfactory sedation, sedation score, separation score, hemodynamic changes and side-effects were recorded.Statistical Analysis Used:Student's t-test.Results:Intranasal Midazolam group had a significantly shorter time for onset of sedation and satisfactory sedation. Mean sedation score and mean separation score at 10 min and 15 min intervals were significant in intranasal Midazolam as compared with normal saline (P < 0.001).Conclusions:Intranasal Midazolam 0.5 mg/kg is safe and effective and provides adequate sedation for easy separation from the parents and reduced requirement of intravenous supplementation during radiological imaging procedures without any untoward side-effects.

Pharmacokinetics and pharmacodynamics of intranasal remimazolam—a randomized controlled clinical trial

“…The reported drowsiness and relaxation responses in this trial demonstrate that sedation via intranasal dosing with remimazolam is feasible, even with a non-optimized formulation. Onset times were faster than those typically reported for midazolam, which is used intranasally with some success, e.g., for imaging or in dental practices [ 11 – 15 ]. A limitation of the current trial design was the use of non-optimized IV formulation, resulting in the need to apply large volumes of either solution or powder in order to achieve clinical effects.…”