Evaluating Clinical Effectiveness and Pharmacokinetic Profile of Atomized Intranasal Midazolam in Children Undergoing Laceration Repair

• Published in: The Journal of emergency medicine Vol. 53; no. 3; pp. 397 - 404
• Main Authors: Mellion, Sarah A., Bourne, David, Brou, Lina, Brent, Alison, Adelgais, Kathleen, Galinkin, Jeffrey, Wathen, Joseph
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2017
• Subjects: Adjuvants, Anesthesia - administration & dosage; Adjuvants, Anesthesia - pharmacokinetics; Administration, Intranasal; Anxiety - prevention & control; anxiolysis; Child; Child, Preschool; Conscious Sedation - methods; Female; Humans; Hypnotics and Sedatives - administration & dosage; Hypnotics and Sedatives - pharmacokinetics; Infant; intranasal midazolam; laceration repair; Lacerations - surgery; Male; Midazolam - administration & dosage; Midazolam - pharmacokinetics; Pain, Procedural - prevention & control; pharmacokinetic; Prospective Studies; laceration repair; anxiolysis; pharmacokinetic; intranasal midazolam
• ISSN: 0736-4679; 2352-5029
• DOI: 10.1016/j.jemermed.2017.05.029

Atomized intranasal midazolam is a common adjunct in pediatrics for procedural anxiolysis. There are no previous studies of validated anxiety scores with pharmacokinetic data to support optimal procedure timing. We describe the clinical and pharmacokinetic profile of atomized intranasal midazolam in children presenting for laceration repair. Children 11 months to 7 years of age and weighing <26 kg received 0.4 mg/kg of atomized intranasal midazolam for simple laceration repair. Blood samples were obtained at 3 time points in each patient, and the data were fit with a 1-compartment model. Patient anxiety was rated with the Observational Scale of Behavioral Distress. Secondary outcomes included use of adjunctive medications, successful completion of procedure, and adverse events. Sixty-two subjects were enrolled, with a mean age of 3.3 years. The median time to peak midazolam concentration was 10.1 min (interquartile range 9.7–10.8 min), and the median time to the procedure was 26 min (interquartile range 21–34 min). There was a trend in higher Observational Scale of Behavioral Distress scores during the procedure. We observed a total of 2 adverse events, 1 episode of vomiting (1.6%) and 1 paradoxical reaction (1.6%). Procedural completion was successful in 97% of patients. Atomized intranasal midazolam is a safe and effective anxiolytic to facilitate laceration repair. The plasma concentration was >90% of the maximum from 5 to 17 min, suggesting this as an ideal procedural timeframe after intranasal midazolam administration.