Wednesday, March 28, 2018

A comparison of two different dosages of oral midazolam in the same pediatric dental


NYU Langone Dental Medicine
Department of Pediatric Dentistry

Resident’s Name: Albert Yamoah, DDS                                                              Date: 3/28/2018
Article TitleA comparison of two different dosages of oral midazolam in the same pediatric dental patients
Author(s):  Peretz B, Kharouba J, Somri M
Journal:  Pediatric Dentistry
Date: 2014
Major TopicOral conscious sedation with oral midazolam
Type of Article: Cohort Study
Main PurposeCompare the efficacy and safety of two different doses of oral midazolam
Key Points
·       Midazolam is a commonly used oral pre-anesthetic medication for children
o   Also used as a sedative agent in the dental setting
·       Midazolam popularity comes from rapid sedative action with anxiolytic and amnesic effects
·       Availability of a reversal agent, flumazenil, for midazolam is an advantage
·       Midazolam is the most lipid-soluble member of the benzodiazepine family
o   lipophilic nature accounts for rapid absorption and metabolism in the GI tract
o   Also accounts for its efficient entry into brain tissues
o   This property produces rapid onset and recovery
·       Midazolam at 0.75 mg/kg with 100% oxygen can enhance outcomes for pediatric dental patients who did not cooperate satisfactorily with a dose of 0.5 mg/kg
·       There were no respiratory events or other adverse effects observed in the same patients receiving dental treatment with either the sedation regimen of 0.5 mg/kg midazolam with nitrous-oxide and oxygen (40 percent and 60 percent, respectively) or 0.75 mg/kg with N2O/O2 (40 percent and 60 percent, respectively).
·       The higher dose of 0.75 mg/kg with N2O/O2 (40 percent and 60 percent, respectively) created a more cooperative patient with a higher mean level of sedation and non-declining level of sedation.
Background
·       Studies on oral midazolam reported that doses ranging from 0.25 to 1.0 mg/kg effectively produced anxiolysis and cooperation, with minimal effects on respiration and oxygen saturation - satisfactory sedation and anxiolysis appear to last for up to 40 to 45 minutes
·       Oral midazolam is rapidly absorbed, with most patients demonstrating a satisfactory degree of sedation and anxiolysis within 10 minutes of administration, and it becomes more effective on more patients as time increases (11-20 minutes
·       Despite the wide usage of midazolam in dentistry, its optimal dosage based on a balance of safety and efficacy in the pediatric dentistry setting has not been well established, although a dose of 0.5 mg/kg seems to be well accepted
·       Pediatric dentists may occasionally encounter a situation in which a dose of 0.5 mg/kg does not seem to achieve patient cooperation and either a higher dose or general anesthesia may be needed
·       Based on the general agreement that 0.5 mg/kg is a recommended dose for oral sedation of pediatric dental patients, the purpose of the present study was to compare the effect of two doses of oral midazolam (0.5 and 0.75 mg/kg) on the same children when no cooperation could be achieved with the lower dose
Purpose
·       Compared the efficacy and safety of two doses of oral midazolam (0.5 mg/kg and 0.75 mg/kg) used on the same children when no cooperation could be achieved with the 0.5 mg/kg dose

Methods
·       All three- to eight-year-olds treated in that clinic between April and May 2012 were evaluated for study entry
·       A total of 430 children were treated during that period, 308 of whom were treated successfully by means of nonpharmacologic behavior management techniques and 42 of whom also received nitrous-oxide and oxygen (N2 O/O2) inhalation sedation.

·       8 children who demonstrated uncooperative behavior were treated by a combination of oral sedation (0.5 mg/kg midazolam) and N2 O/O2 (40 percent and 60 percent, respectively), and the treatment was successful in 57 children.
·       The treatment was not successful in 23 patients who continued to be uncooperative with the combination of oral sedation and N2 O/O2 (40 percent and 60 percent, respectively).
·       These 23 children and their parents participated in the current investigation
·       Level of sedation, cooperation, parental satisfaction, parental prediction of child's future anxiety, and outcome of sedation with the two doses were evaluated
·       All treatments and behavioral evaluations were conducted by the same non-blinded dentist
·       Parental evaluations were non-blinded as well

Results:
·       No respiratory events or other adverse effects were observed with either regimen.
·       There was no gender difference in any parameter regarding the two doses of midazolam.
·       No treatment was aborted with the 0.75 mg/kg dose.
·       Sedation and cooperation were significantly higher at baseline and after 15, 30, and 45 minutes (P=.001) for the 0.75 mg/kg group.
·       Parental satisfaction with the treatment was significantly greater with the higher dose.
·       Overall study findings showed that the maximum mean level of sedation was 3.61, which is considered moderate on the Wisconsin sedation scale, and it never reached a deep sedation stage.
·       The maximum mean level of cooperation was 3.78, which is between fair and good on the Houpt behavioral rating scale.
·       The findings on cooperation were significantly better for the 0.75 mg/kg dose than the 0.5 mg/kg dose.
o   A previous study comparing three doses of oral midazolam (0.25, 0.5, and 1 mg/kg) unexpectedly found that the smallest dose (0.25 mg/kg) was equally as effective as the two higher doses.

Conclusion:
·       Midazolam at 0.75 mg/kg with 100% oxygen can enhance outcomes for pediatric dental patients who did not cooperate satisfactorily with a dose of 0.5 mg/kg
·       There were no respiratory events or other adverse effects observed in the same patients receiving dental treatment with either the sedation regimen of 0.5 mg/kg midazolam with nitrous-oxide and oxygen (40 percent and 60 percent, respectively) or 0.75 mg/kg with N2O/O2 (40 percent and 60 percent, respectively).
·       The higher dose of 0.75 mg/kg with N2O/O2 (40 percent and 60 percent, respectively) created a more cooperative patient with a higher mean level of sedation and non-declining level of sedation.
Assessment of ArticleThe relatively small number of patients who were included in the study precluded further and more refined analytic tests. In addition, the operating dentist, who was also the evaluator, knew which dose was given each time. Therefore, the finding that all patients who were given the 0.75 mg/kg for the second attempt were treated successfully with no case of aborted treatment must be considered with some caution, since the desire for positive results could bias the provider as well as the parents in completing all necessary treatment. Further studies with larger study populations are required to gain a better view of the effect of oral midazolam on the cooperation of pediatric dental patients.

Level of Evidence/Comments: II-2


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