Optimal Dose for Sedation in Kids

TOPLINE:

Administering intranasal midazolam at doses of 0.4 and 0.5 mg/kg was found to be optimal for sedation in children undergoing laceration repair, resulting in no serious adverse events.

METHODOLOGY:

• Researchers conducted a randomized clinical trial of 101 children aged 6 months to 7 years (median age, 3 years; 37.6% girls) who had a simple laceration and received intranasal midazolam in a US emergency department to facilitate repair (September 2021-May 2024).
• To determine the optimal dose of intranasal midazolam for achieving sedation, participants were randomly assigned to receive 0.2, 0.3, 0.4, or 0.5 mg/kg of the drug, with a concentration of 5 mg/mL administered using a mucosal atomization device.
• The primary outcome was adequate sedation, defined as having a score of 2, 3, or 4 on the Pediatric Sedation State Scale for at least 95% of the scored procedure, with the procedure starting within 17 minutes of administering intranasal midazolam and being completed successfully.
• Secondary outcomes included ideal sedation state, time to the onset of minimal sedation, adverse events, and satisfaction of clinicians and caregivers with the sedation process.

TAKEAWAY:

• A total of 19 children received 0.2 mg/kg of intranasal midazolam, 24 received 0.3 mg/kg, 29 received 0.4 mg/kg, and 29 received 0.5 mg/kg. The 0.2 and 0.3 mg/kg doses were eliminated due to lower rates of  sedation efficacy.
• The 0.4 and 0.5 mg/kg doses of intranasal midazolam were found to be optimal for achieving adequate sedation in children.
• No differences in secondary outcomes were observed between the 0.4 and 0.5 mg/kg groups.
• No serious adverse events were reported. A paradoxic reaction was noted in one child receiving 0.4 mg/kg of intranasal midazolam.

IN PRACTICE:

“Our findings support the use of 0.4 or 0.5 mg/kg of IN [intranasal] midazolam to optimize the chance of achieving adequate sedation state in children undergoing laceration repair,” the researchers reported.

“Our study did not provide data supporting the preferential use of 0.4 or 0.5 mg/kg as neither dose was eliminated as part of the sequential selection procedure (indicating that neither dose was considered superior to the other in achieving adequate sedation state), and there were no differences between the two doses in the secondary outcomes evaluated,” they added.

SOURCE:

This study was led by Daniel S. Tsze, MD, MPH, of the Department of Emergency Medicine at the Vagelos College of Physicians and Surgeons, Columbia University in New York City. It was published online on July 28, 2025, in JAMA Pediatrics.

LIMITATIONS:

Children with developmental delays or autism spectrum disorder were not included, thereby limiting generalizability to these groups. Children younger than 6 months were also not enrolled, and the findings may not apply to more invasive procedures beyond laceration repair.

DISCLOSURES:

This study was supported by the Emergency Medicine Foundation and Columbia University’s CTSA grant from the National Center for Advancing Translational Sciences, National Institutes of Health. Some authors disclosed receiving grants from the Emergency Medicine Foundation during the study and from other sources outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.