Oral Sedation With and Without Nitrous Oxide

Study Overview
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Brief Summary
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Aims: The objective of the current study was to evaluate the effectiveness of oral midazolam-hydroxyzine with/without nitrous oxide. Design: This was a randomized split mouth, cross over and triple-blinded clinical study. Thirty uncooperative healthy children aged six to nine, whose needed dental treatments.

Detailed Description
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The purpose of this study was to compare the efficacy of combining oral midazolam-hydroxyzine with/without N2O/O2 in sedating uncooperative schoolchildren undergoing dental treatment. Thirty uncooperative healthy children aged six to nine were randomly selected to receive either one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 100% O2 (regimen A), or one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 50% N2O/O2 (regimen B) in a crossover design. Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment phase (injection, rubber dam RD, operating high-speed handpiece with touching the tooth without drilling) and the treatment phase (drilling, restoration).

Official Title
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Oral Sedation With/Without Nitrous Oxide in Pediatric Dental Patients

Conditions
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Behavior, Child

Intervention / Treatment
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* Drug: Midazolam-hydroxyzine with 100% O2
* Drug: Midazolam-hydroxyzine with 50% N2O/O2


Participation Criteria
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Eligibility Criteria
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Criteria: Inclusion Criteria: ASA Classification I. minimum weight of 18 kg uncooperative children scored 1 or 2 on Frankle Scale. requiring nonemergency, bilateral mandibular dental treatments under local anesthesia. Exclusion Criteria: known allergy to midazolam and/or hydroxyzine. upper respiratory tract infection with nasal discharge.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 9 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: Crossover Assignment
Interventional Model Description: blinded, randomized controlled trial, comparing two groups.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A: Midazolam-hydroxyzine with 100% O2<br>Midazolam-hydroxyzine with 100% O2 was administrated to 30 children. Drug: Oral Medication (midazolam 7.5 mg and hydroxyzine 10 mg) and Inhalation Gas 100% O2 Patients were randomly assigned to received one of two regimens (A,B) in across over design, Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases. | Drug: Midazolam-hydroxyzine with 100% O2<br>* Patients received Oral Sedatives with 100% O2 ,Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.<br>* Other names: A;|
| Experimental: Midazolam-hydroxyzine with 50% N2O/ O2<br>children received Midazolam-hydroxyzine with 50% N2O/O2, one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 50% N2O/O2. Drug: Oral Medication and Inhalation Gas Patients were randomly assigned to received one of two regimens (A,B) in across over design, Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases. | Drug: Midazolam-hydroxyzine with 50% N2O/O2<br>* Patients received Oral Sedatives with 50% nitrous ,Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.<br>* Other names: B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior improvement on the modified Houpt behavioral rating scale | Behavior assessment improvement related to the addition of N2O/O2 to the combination midazolam-hydroxyzine. | Behavior will assess at the end of the session (about 30-90 min) by evaluating the sessions 's videotapes using overall assessment (range from 1 to 4, higher values represent a better outcome) of the modified Houpt behavioral rating scale | 
| Behavior improvement on the modified Houpt behavioral rating scale | Behavior assessment improvement related to the addition of N2O/O2 to the combination midazolam-hydroxyzine. | Behavior assess after 30 min of oral medications administered by evaluate the sessions's videotapes using of Sleep,movement,Head/oral resistance,Cry,Verbal assessments(range1- 4,higher values is the better outcome)of modified Houpt behavioral scale | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midazolam, hydroxyzine, oxygen, behavior, child, tooth