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Title Oral Midazolam and Intranasal Midazolam are equally effective when used for conscious sedations in short procedures in pediatric dentistry.
Clinical Question For a dental pediatric patient, will intranasal midazolam as compared to oral midazolam be more effective for use in conscious sedation?
Clinical Bottom Line For dental pediatric patient intranasal midazolam and oral midazolam are equally effective when used in conscious sedation in short procedures in pediatric dentistry. Intranasal midazolam has a shorter onset and shorter working time when compared to oral midazolam. It is important to take the onset time and duration time into consideration when deciding which medications to use for treatment of pediatric 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) 25939638Musani/201530 pediatric patients between the ages of 4 and 10 years who needed dental treatmentRandomized Controlled Trial
Key results30 pediatric patients between the ages of 4 and 10 years were randomly divided into two equal groups.One group received oral midazolam and nitrous oxide sedation on the first visit and on a second visit, received intranasal midazolam and nitrous oxide. The other group was vice versa. Oral midazolam was calculated at 0.2 mg/kg of the subject's weight. The nasal midazolam was calculated at 0.1 mg/kg the subject’s weight. The concentration of nitrous oxide utilized in the study was 30%. The behavior of all subjects was monitored throughout.The mean onset of action of oral midazolam was 20.1 minutes and for nasal midazolam was 12.1 minutes, these differences are considered statistically significant. The second group had higher alertness. However,there were no statistically significant differences in behavior between the two groups.
#2) 22424753Özen/2011240 healthy children between the ages of 4 and 6 years who needed dental treatment and who behavior that could not be managed by traditional techniques or who had negative behavior. Randomized Controlled Trial
Key resultsPatients were randomly placed into four groups. Group one received 0.20 mg/kg midazolam intranasal and 50% Nitrous oxide, Group two received 0.75 mg/kg of midazolam orally and 50% nitrous oxide, Group three received 0.50 mg/kg of midazolam orally with 50% nitrous oxide, and group 4 received inhalation sedation with 50% nitrous oxide. The rates were as follows: group 1 -87%, group 2 - 79%, group 3 -72%,group 4 - 55%. There were no statistical differences in success rates between group 1 and group 2 but there was between group 1 and 3. Group 2 had the highest level of sedation.
#3) 20557707Johnson/201031 children ages 42-48 months old, ASA I, 15kg minimum weight, needing dental treatment in at least 2 quadrants and who are unable to cooperate. Randomized Controlled Trial
Key resultsThe patients were randomly assigned into two groups. One group received 0.5 mg/kg oral midazolam with an intranasal saline placebo.The other group received 0.3 mg/kg intranasal midazolam with an oral placebo. Oxygen saturation was decreased at t=20 minutes and t=25 minutes for the group that received the oral treatment. This group also exhibited better behavior during the first 20 minutes while the intranasal group exhibited better behavior after 20 minutes. It was determined that oral sedation is more successful when compared to the intranasal sedation.
#4) 25939638Lee-Kim/200440 children between the ages of 24 to 72 months who presented Early Childhood Caries, ASA I, needed more than one visit for dental treatment and presented negative behavior. Randomized Controlled Trial
Key resultsPatients were randomly assigned to two groups, oral or intranasal midazolam administration. Patients received 45% nitrous oxide along with the midazolam. The mean onset time for intraoral midazolam was 15.5 ± 5 minutes while for intranasal was 5.55 ± 2.2 minutes. These differences were statistically significant. The mean working times for intraoral sedation was 38.1 ± 7.58 minutes while for intranasal was 29.3 ± 11.6 minutes. Between 25 and 39 minutes, after sedation began, patients who received intranasal treatment displayed increased movement and less sleep. Both groups became alert between 30 and 35 minutes after administration of midazolam.
Evidence Search ((((("child"[MeSH Terms] OR "child"[All Fields] OR "children"[All Fields]) AND sedation[All Fields]) AND (intranasal[All Fields] AND ("midazolam"[MeSH Terms] OR "midazolam"[All Fields]))) AND (("mouth"[MeSH Terms] OR "mouth"[All Fields] OR "oral"[All Fields]) AND ("midazolam"[MeSH Terms] OR "midazolam"[All Fields]))) NOT ("ketamine"[MeSH Terms] OR "ketamine"[All Fields])) AND ("dentistry"[MeSH Terms] OR "dentistry"[All Fields])
Comments on
The Evidence
All studies cited maintain validity throughout. In the Musani study, test and controls were divided equally and treated equally. There was no report of study attrition. Although treatment and observation were over the course of two different appointments and allowed for better data correlation, using such a wide age group could affect and bias results because older children may be able to cooperate more fully, compared to younger.The study by Özen et al. provided controlled distribution by sex and age. Participants were randomly divided and received different types of sedation with 100% success in providing treatment. over the course of one year and no attrition. In Johnson et al. participant age is similar to Özen et al. although, specified a minimum weight to qualify for the study. When compared to the other studies, Lee-Kim et al used the youngest age group (24 to 72 months)with no attrition. All of these studies demonstrate that both intranasal and oral midazolam are very effective and safe when treating young children. Perspective: In pediatric dentistry, both intranasal and oral midazolam are good options for conscious sedation. These studies show that both methods are equally effective. Considerations include; type of procedures needed and working time required. Intranasal midazolam provides a shorter working time compared to oral delivery. Further studies, using the same age groups and a meta-analysis of data would provide additional evidence for this topic.
Applicability It is common practice to use oral conscious sedation to treat pediatric patients in dentistry. The use of intranasal and the oral midazolam are equally effective when performing short dental procedures for pediatric patients. When choosing between one route versus the other, best practice is to consider onset, working time of the medications, type of procedure to be performed, as well as possible discomfort the medication may cause to the patient. .
Specialty/Discipline (General Dentistry) (Pediatric Dentistry) (Restorative Dentistry)
Keywords Intranasal midazolam, pediatric dentistry, sedation, oral midazolam
ID# 3283
Date of submission: 11/13/2017spacer
E-mail leonpineda@livemail.uthscsa.edu
Author Cristina Leon-Pineda
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