Efficacy of Midazolam in Outpatient Pediatric Dentistry: A Systematic Review

Abstract

Aims: The aim of this systematic review was to analyze the efficacy, advantages and adverse effects of midazolam in outpatient pediatric dentistry.

Methods: This review was carried out in accordance with the PRISMA criteria. A systematic electronic search was conducted through MEDLINE/PubMed, Scopus, and the Cochrane Library databases up to September 2024. An advanced and reproducible search strategy was used to identify relevant studies. Articles were excluded if they focused solely on midazolam as a premedication for general anesthesia or elective surgery, involving patients with special diseases. Inclusion criteria required participants aged 0-16 years, patients with behavioral and/or cooperation disorders and undergoing simple dental restorative procedures under local anesthesia, such as fillings, pulp therapies, stainless steel crowns, or basic extractions. Patients with specific medical conditions, as well as those who were not monitored for vital signs during sedation, were excluded from the study. The risk of bias assessment was analyzed using the criteria set out in the Cochrane Handbook for Systematic Reviews of Interventions, version 5.1.0.

Results: A total of 28 studies were included in the analysis, which were conducted across 11 countries and involved a total of 4374 children aged between 2 and 14 years. Most studies demonstrated a low risk of bias. Many of the participants were ASA I or II status and were assessed using behavioral scales, primarily the Frankl scale. Twelve adjunct drugs were combined with midazolam, and various administration routes were explored, including oral, intranasal, and buccal. Dosing protocols varied, as did fasting guidelines prior to sedation. Outcome measures included vital sign monitoring and behavioral assessments, most commonly via the Houpt and MOAA/S scales. Midazolam generally proved effective in reducing anxiety and improving cooperation, with reported benefits extending to future dental visits. Adverse effects were infrequently noted and typically mild, including nausea, vomiting, and paradoxical reactions.

Conclusions: Midazolam has been shown to be an effective and safe agent for moderate sedation in pediatric dental procedures when administered orally at a dose range of 0.3-0.5 mg/kg. The evidence suggests that it reliably reduces anxiety and improves cooperation. Supervision, preferably by an anesthesiologist, is recommended when combined with other drugs to ensure patient safety.

Keywords: conscious sedation; dental anxiety; midazolam; pediatric dentistry.

FIGURE 1

Flow chart of the study selection process (PRISMA).

FIGURE 2

(a) Risk of bias assessment. According to the Cochrane Handbook for Systematic Reviews of Interventions, version 5.1.0. (+): low risk of bias; (–): high risk of bias; (?): uncertain risk of bias. Studies with low risk of bias (in alphabetical order). (b) Risk of bias assessment. According to the Cochrane Handbook for Systematic Reviews of Interventions, version 5.1.0. (+): low risk of bias; (–): high risk of bias; (?): uncertain risk of bias. Studies with high or unclear risk of bias (in alphabetical order).