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Literature Review

A randomized clinical trial comparing oral, aerosolized, intranasal, and aerosolized buccal midazolam

Ann Emerg Med.  2011 Oct;58(4):323-9

Reviewed by Daniel Tsze, MD

This article is the first study to compare two routes of administering midazolam with the traditional oral route to facilitate laceration repair in children. It provides evidence as to whether or not they are viable alternatives to oral midazolam; and describes how well each route performs by measuring relevant clinical outcomes.
This was a randomized controlled trial that compared oral midazolam (0.5 mg/kg, max dose 15 mg), intranasal midazolam, and buccal midazolam (both 0.3 mg/kg, max dose 10 mg, administered with an atomization device). Authors measured effectiveness in reducing the distress of laceration repair in children aged 6 months to 7 years.

The primary outcome was the amount of distress experienced by the patient after the procedure started, which was measured by the first CHEOPS score taken after the laceration repair began.  There was significantly less distress in the buccal group compared to the oral group, whereas the intranasal group was not significantly better at providing stress relief when compared to the oral group.

The intranasal midazolam cohort appeared to produce better results when secondary outcomes were examined:  it had a faster onset of sedation; a greater proportion of patients achieving adequate sedation; a greater proportion of patients with optimal activity scores (i.e. a 5-point score indicating level of sedation); and a higher rate of parents who would choose the same regimen again.  On the other hand, the intranasal route was associated with the most irritation on administration and the smallest proportion of patients who accepted the medication easily.

Although the study primarily intended to compare the intranasal or buccal administration with the oral route, it is also interesting to compare outcomes between the intranasal and buccal groups.  There is a significantly greater number of patients who achieve adequate sedation in the intranasal group (approx. 85%) compared to the buccal group (approx 60%). Intranasal administration was also associated with faster sedation onset - similar to the differences observed between the intranasal and oral groups.

It appears that buccal and intranasal midazolam are both viable, non-invasive, alternatives for administering midazolam to facilitate pediatric laceration repair.  Although buccal midazolam appears to produce the greatest overall degree of anxiolysis at the beginning of the procedure (between all of the routes), it produced a similar number of children who were inadequately prior to the procedure when compared to oral administration. Intranasal administration resulted in the greatest percentage of non-distressed children prior to the procedure. The advantages proffered by the intranasal route may make it appear more favourable by some clinicians, but the choice of one route over another must also be weighed in light of the aforementioned disadvantages as well, as well as any other patient characteristics that may impede intranasal administration, such as nasal congestion or nasal wounds.  Ultimately, this study provides useful information which will help clinicians individualize sedation for each patient more effectively.

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