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A Randomized Clinical Trial Comparing Oral, Aerosolized Intranasal, and Aerosolized Buccal Midazolam - 24/09/11

Doi : 10.1016/j.annemergmed.2011.05.016 
Eileen J. Klein, MD, MPH a, b, , Julie C. Brown, MDCM, MPH a, b, Ana Kobayashi, MPH a, Daniel Osincup, BA a, Kristy Seidel, MS a
a Seattle Children's Hospital, Seattle, WA 
b University of Washington School of Medicine, Department of Pediatrics, Division of Emergency Medicine, Seattle, WA 

Address for correspondence: Eileen J. Klein, MD, MPH

Résumé

Study objective

We determine whether aerosolized intranasal or buccal midazolam reduces the distress of pediatric laceration repair compared with oral midazolam.

Methods

Children aged 0.5 to 7 years and needing nonparenteral 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 with the oral route group (P=.04; difference −2; 95% confidence interval −4 to 0) and a corresponding nonsignificant trend for the intranasal route (P=.08; difference −1; 95% confidence interval −3 to 1). Secondary outcomes (177 subjects) favored the intranasal group, including a greater proportion of patients 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 administration. Adverse events were similar between groups.

Conclusion

When comparing the administration of midazolam by 3 routes to facilitate pediatric laceration repair, we observed slightly less distress in the aerosolized buccal group. The intranasal route demonstrated a greater proportion of patients 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 administration. Aerosolized buccal or intranasal midazolam represents an effective and useful alternative to oral midazolam for sedation for laceration repair.

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 Please see page 324 for the Editor's Capsule Summary of this article.
 Provide process.asp?qs_id=6994 on this article at the journal's Web site, www.annemergmed.com.
 A podcast for this article is available at www.annemergmed.com.
 Supervising editor: Steven M. Green, MD
 Author contributions: EJK conceived the study, designed the trial, obtained research funding, provided oversight for data and data analysis, and drafted the article. EJK and JB supervised the conduct of the trial and data collection. EJK, JCB, AK, and DO undertook recruitment of patients and managed the data, including quality control. KS provided statistical advice on study design and analyzed the data. All authors contributed substantially to revision of the article. EJK takes responsibility for the paper as a whole.
 Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist. This study was supported by the Thrasher Foundation and by CTSA grant number 1 UL1 RR025014-02 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH). Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH.
 Publication date: Available online June 19, 2011.


© 2011  American College of Emergency Physicians. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 58 - N° 4

P. 323-329 - octobre 2011 Retour au numéro
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