What’s the Ideal Intranasal Midazolam Dose for Peds Sedation?

Written by Vivian Lei

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For pediatric laceration repair, intranasal midazolam 0.4–0.5 mg/kg provides the best balance of efficacy and safety.

Sniffing out the sweet spot for IN midazolam
Intranasal (IN) midazolam is a popular choice for pediatric procedural sedation in the ED, but dosing practices have historically varied widely. This prospective, double-blind, adaptive selection, randomized clinical trial enrolled 101 children (6 months to 7 years) undergoing laceration repair to identify the optimal dose of IN midazolam (0.2, 0.3, 0.4, or 0.5 mg/kg). The primary outcome was achieving an “adequate sedation state,” defined using the validated Pediatric Sedation State Scale (PSSS) for at least 95% of the procedure, with timely procedure start (<17 min post-dose) and completion. Secondary outcomes included level of sedation, time to onset of minimal sedation, time to recovery, clinician/caregiver satisfaction, and adverse events.

Using an adaptive sequential elimination design, the 0.2 and 0.3 mg/kg groups were dropped early due to lower rates of adequate sedation. The 0.4 and 0.5 mg/kg groups remained through study completion, and no meaningful differences were found between them in secondary outcomes. Adequate sedation was achieved in roughly 65–70% of children in both groups, with a median onset of about 4 minutes and no serious adverse events. Recovery was rapid and satisfaction rates were high. A single paradoxical reaction occurred in a patient receiving the 0.4 mg/kg dose, and minor adverse events were rare.

How will this change my practice?
This study supports 0.4–0.5 mg/kg as the optimal IN midazolam dosing range for simple laceration repair in children. Lower doses are more likely to result in inadequate sedation, which can increase patient distress and long-term negative associations with care. Importantly, higher dosing did not prolong recovery or increase adverse events in this cohort. While success rates remain lower than with IV agents, IN midazolam remains a valuable, needle-sparing option for straightforward, short procedures.

Editor’s note: For over 20 years, I have used 0.5mg/kg, max 10mg, for IN midazolam. Allow 10 minutes to peak. ~Clay Smith

Source
Optimal Dose of Intranasal Midazolam for Procedural Sedation in Children: A Randomized Clinical Trial. JAMA Pediatr. 2025 Jul 28:e252181. doi: 10.1001/jamapediatrics.2025.2181. Epub ahead of print. PMID: 40720114; PMCID: PMC12305440.