A Randomized Clinical Trial Comparing Oral, Aerosolized Intranasal, and Aerosolized Buccal Midazolam

Abstract

Study Objective To determine whether aerosolized intranasal or buccal midazolam reduces the distress of pediatric laceration repair compared to oral midazolam. Methods Children 0.5–7 years old needing non-parenteral sedation for laceration repair were randomized to receive oral, aerosolized intranasal, or aerosolized buccal midazolam. Patient distress was rated by blinded review of videotapes using the Children’s Hospital of Eastern Ontario Pain Score. Secondary outcomes included activity scores, sedation adequacy, sedation onset, satisfaction, and adverse events. Results For the 169 subjects (median age 3.1 years) evaluated for the primary outcome, we found significantly less distress in the buccal midazolam group compared to oral route (p=0.04; difference −2, 95% CI −4, 0), and a corresponding non-significant trend for the intranasal route (p=0.08; difference −1, 95% CI −3, 1). Secondary outcomes (177 subjects) favored the intranasal group, including a greater proportion with an optimal activity score (74%), a greater proportion of parents wanting this sedation in the future, and faster sedation onset. Intranasal was the route least tolerated at the time of administration. Adverse events were similar between groups. Conclusions When comparing the administration of midazolam by 3 routes to facilitate pediatric laceration repair, we noted slightly less distress in the aerosolized buccal group. The intranasal route demonstrated a greater proportion with optimal activity scores, greater proportions of parents wanting similar sedation in the future and faster onset, but was also the most poorly tolerated at the time of administration. Aerosolized buccal or intranasal midazolam represent effective and useful alternatives to oral midazolam for sedation for laceration repair.

Premedication with midazolam for urethral catheterization of febrile infants

“…Importantly, despite the fact that all study patients were febrile, there were no significant adverse reactions including at 48 h follow-up. This finding is consistent with recent studies that show that midazolam, administered orally or intranasally, has a good safety profile [9].…”

Relief of Pain and Anxiety in Pediatric Patients in Emergency Medical Systems

“…54,191 Drug delivery into the central nervous system is greatly enhanced with the use of an atomizer that distributes the medication more evenly to the mucous membranes. [192][193][194] Because adverse events are still possible when this mode of opiate administration is used, care should be taken when using adjunctive medications, such as benzodiazepines. In addition, if there is no IV access, it is prudent to prepare for alternative methods of administration for reversal agents.…”

Intranasal midazolam for anxiolysis in closed reduction of nasal fractures in children

“…Intranasal midazolam's rapid onset, short duration, and ease of administration make it ideal for anxiolysis in shorter procedures like closed reduction of nasal fractures [1,5,6]. Such anxiolysis enhances patient cooperation and increases patient and parent satisfaction [1,5,6].…”

“…Topical intranasal midazolam has been used successfully to reduce preoperative anxiety and increase cooperation of pediatric patients in laceration repairs, dental procedures, imaging studies and prior to induction of general anesthesia [1][2][3][4][5][6][7]. However, there are no reports on the use of intranasal midazolam for reduction of isolated nasal bone fractures.…”