Oral Sedation With and Without Nitrous Oxide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-17

Study Completion Date

2019-01-06

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.

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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).

Conditions

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Behavior, Child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

blinded, randomized controlled trial, comparing two groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Triple (Participant, Care Provider, Outcomes Assessor) Each of the children/parents, the dentist and the outcomes assessors were blinded. To ensure the blindness of the dentist, the inhalation sedation machine was placed in a way that he could not see the flow rate panel or the type of the administered gases.

Study Groups

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A: Midazolam-hydroxyzine with 100% O2

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.

Group Type ACTIVE_COMPARATOR

Midazolam-hydroxyzine with 100% O2

Intervention Type DRUG

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.

Midazolam-hydroxyzine with 50% N2O/ O2

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.

Group Type EXPERIMENTAL

Midazolam-hydroxyzine with 50% N2O/O2

Intervention Type DRUG

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.

Interventions

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Midazolam-hydroxyzine with 100% O2

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.

Intervention Type DRUG

Midazolam-hydroxyzine with 50% N2O/O2

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.

Intervention Type DRUG

Other Intervention Names

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A B

Eligibility Criteria

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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.