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How safe is oral midazolam sedation in pediatric dentistry?


This summary is based on the article published in the International Journal of Pediatric Dentistry: Safety of oral midazolam sedation use in pediatric dentistry: a review (January 2014)


Young children needing multiple procedures often cannot be managed using local anesthesia alone. General anesthesia (GA) is an alternative, but is associated with significant morbidity and expense.  Sedation is a possible alternative to GA for behaviour management but evidence in support of its use is weak.

A recent systematic review noted that oral midazolam is one of the few agents available whose efficacy in dental procedures for children is supported by evidence. Midazolam is potentially an ideal sedative agent for pediatric dentistry because it can be administered orally, has anxiolytic and anterograde amnesic effects, and is short acting. 

Purpose of the Study

Little information is available as to the safety of this drug when used as an oral sedative in children needing dental treatment. Therefore, it is important to evaluate the side effects and any other adverse outcomes following use of oral midazolam for behaviour management in pediatric dentistry.

Key Messages

  • There appear to be rare significant side effects associated with oral midazolam use for behaviour management in children and adolescents requiring dental treatment.
  • Minor side effects are more common, but determining precise figures is complicated by poor reporting.

Clinical Significance

  • There is currently little information available as to the safety of midazolam when used as an oral sedative in children needing dental treatment.
  • This study revealed that significant side effects are uncommon. Minor side effects are more common, with paradoxical reactions, nausea and vomiting being the chief complaints.
  • The frequency of transient desaturations emphasizes the importance of adequate monitoring during sedation.
  • The study highlights the need for more consistent reporting of adverse effects.


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  1. Name January 7, 2014

    I have used this treatment modality for children ages 4-10 for several years and have had good success with only one incidence of heightened anxiety or paradoxical – type reaction. I have used 0.5mg/kg as my dosing standard. I find that this dose is the minimum for the majority of patients to be adequately sedated. The level of sedation varies, but is usually light, although I recently had one child become very hard to arouse after about 40 minutes. This child had had a very exhausting day and the parent said he would likely “crash” hard in the dental chair. The child had excellent vitals throughout the procedure but emphasized a “varied” response to the sedative.

  2. Richard January 14, 2014

    A child just died in Hawaii because of a practitioner’s inability to monitor an unprotected airway with oral sedation. This article is wrong when it says that general anesthesia is associated with significant morbidity, it is not. Expense yes, morbidity NO. Oral sedation and an unprotected airway, lack of training in sedation, inability to keep saturation levels up on a sedated child has far higher morbidity, just google pediatric dental deaths, virtually all are associated with sedation. As well, most dentists don’t know of the additive effects of sedation, local anesthesia, etc. and overdose children in most cases.

  3. Dr. Robert Wolanski January 14, 2014

    I agree with the previous post. We have trained in the DOCS pediatric sedation protocol and have also had similar results over the past few years. Our dosing range is from )0.3 mg/kg to 0.75 mg/kg. We generally prefer the higher dosing level. After practicing 26 years, I can certainly say that nothing used in the past comes close to the predictability of midazolam sedation. In my opinion one must utilize continuous monitoring including capnography and be PALS certified. Dr. Roger Sangers offices in California have vast experience (much more than I) having recorded over 10,000 cases . I have great respect for their experience and opinions. I am sure they would be happy to participate in this discussion. I am greatful for the training we have received to be able to treat otherwise untreatable patients.

  4. Anonymous January 14, 2014

    What were the patient’s vital signs???


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