Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care

Study Overview
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Brief Summary
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The general objective of the study is to compare the efficacy of administering midazolam orally as syrup versus nasally with nasal atomizer. The specific objectives are to measure: 1) acceptability of the medication, 2) effect on behavior, 3) time of onset, 4) maximum working time.

Detailed Description
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Prospective, parallel design Study and control group: 100 healthy children (ASA 1), ages: 2-6 years, uncooperative (Frankl 1-2), that needs at least two similar dental treatments. Exclusion criteria: enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 = >75% airway obstruction), upper respiratory tract infection or nasal discharge. Randomization: At the first appointment the subjects will assigned randomly to receive oral midazolam or nasal midazolam; Sedation: oral midazolam dose is 0.5mg/kg. Nasal midazolam dose is 0.2mg/kg. During treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. Acceptability of the medication: compliance in taking the medication will be assessed and recorded as: willingly, coaxed, forced, or failed (not administered). Behavior during dental treatment: Houpt scale measures behavior by rating sleep, movement, crying and overall behavior. The degree of alertness, movement and crying will be assessed before, during (every 5 min) and after the operative procedure. The rating will be done by one observer blind to the route of administration. This blind observer will also monitor the pulse and oxygen saturation.

Official Title
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Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care

Conditions
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Conscious Sedation

Intervention / Treatment
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* Drug: oral midazolam
* Drug: nasal midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy children (ASA 1), uncooperative (Frankl 1-210), that needs at least two similar dental treatments. Exclusion Criteria: enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 = >75% airway obstruction), upper respiratory tract infection or nasal discharge.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral sedation<br>administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. | Drug: oral midazolam<br>* administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.<br>* Other names: oral dormicum;|
| Active Comparator: nasal sedation<br>administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. | Drug: nasal midazolam<br>* administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.<br>* Other names: nasal dormicum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Compliant With Oral or Nasal Midazolam Administration | the compliance in taking the medication will be assessed at the time of administration by one of the investigators and recorded immediately as: willingly, coaxed, forced, or failed (not administered). | the compliance in taking the medication will be assessed at the time of administration and recorded immediately. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior During Dental Treatment | the effect of oral or nasal midazolam on behaviour will be assessed by blind observer using Houpt scale. Houpt scale measures behavior by rating overall behavior. the scale is 1 to 6, higher score mean a better behavior. = Aborted, no treatment rendered. = Poor, treatment interrupted, only partial treatment was completed 3= Fair, treatment interrupted but eventually completed 4= Good, difficult but all treatment was performed 5= Very good, some limited crying or movement 6= Excellent, no crying or movement | the effect of oral or nasal midazolam on behaviour will be assessed during dental treatment.The length of each treatment is estimated as 30-45 minutes. |