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Title The Optimal Dose for Oral Midazolam in Order to Achieve Effective Sedation Levels in Pediatric Patients is 0.75mg/kg, as shown by a single trial of ninety patients.
Clinical Question What is the optimal dosage of oral midazolam in order to achieve effective sedation levels in pediatric dental patients?
Clinical Bottom Line For pediatric dental patients, the oral dose of midazolam of 0.75mg/kg has a high level of sedation and cooperation, without increasing adverse effects, as opposed to the standard dose of 0.5mg/kg. This is based on a single trial of ninety patients.
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 22040450Somri/20123 trials of 30 patients each, N=90 children ages three to ten years oldRandomized Controlled Trial
Key resultsPatients were randomly assigned to three groups of thirty patients each, and were administered 0.5mg/kg in Group A, 0.75 in Group B, or 1mg/kg oral midazolam in Group C. Onset time for group B (22+-4.3min) was lower than Group A (26.3 +-3.7min). Sedation scores and cooperation scores in group B and C were higher than group A (P<0.001). Groups B or C had no statistic difference between onset time or sedation scores. With increasing dose, the discharge time increased significantly. Group A demonstrated the shortest discharge time, followed by groups B and C (P<0.001 ANOVA). No cardiovascular or apnea events occurred in any of the three groups. No respiratory events occurred in Group A, compared to 4/30 in Group B that required external maneuvers (EM) to maintain airway patency, and 10/30 in Group C where six patients required EM and four patients had oxygen desaturation of <94% for more than 30 seconds. Group A and C had a significant difference in nausea and vomiting side effects, with Group A having 3/30 patients experience, and Group C 12/30 experienced side effects (P=0.016).
Evidence Search ("mouth"[MeSH Terms] OR "mouth"[All Fields] OR "oral"[All Fields]) AND ("child"[MeSH Terms] OR "child"[All Fields]) AND ("conscious sedation"[MeSH Terms] OR ("conscious"[All Fields] AND "sedation"[All Fields]) OR "conscious sedation"[All Fields]) AND ("midazolam"[MeSH Terms] OR "midazolam"[All Fields])
Comments on
The Evidence
Validity: All patients were initially recruited after they were unable to comply with behavioral management techniques and/or nitrous oxide. If any of the patients exhibited any of the following including higher risk for potential airway obstruction events, disorders of the gastrointestinal tract that would adversely affect absorption of the oral sedation drugs, “altered mental status”, or anemia, with hemoglobin below 10gr/DL, lack of parental consent, or conscious sedation failure previously they were eliminated from the trial. In each group there was no significant difference in patient age or weight. Each group was evaluated double-blinded. Completion rate was greater than 80%. There were no competing interests. Perspective: The recommended dose for midazolam currently is 0.25-0.5mg/kg, but as the study demonstrated, higher sedation and compliance was found with 0.75mg/kg without an increase in adverse side effects.
Applicability Oral conscious sedation is an important method, especially in pediatric dentistry, in order to get patient compliance. It is important to know the optimal dose of oral midazolam at which the greatest amount of benefit will be achieved, with the least amount of adverse effects.
Specialty/Discipline (Pediatric Dentistry)
Keywords Oral conscious sedation, pediatric, midazolam, optimal dose
ID# 3045
Date of submission: 03/17/2016spacer
E-mail wiegandj@livemail.uthscsa.edu
Author Julia Wiegand
Co-author(s) e-mail
Faculty mentor/Co-author Maria Cervantes Mendez, DDS MS
Faculty mentor/Co-author e-mail CervantesMen@uthscsa.edu
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