Oral Sedation With and Without Nitrous Oxide

Phase 3

Completed

• Conditions: Behavior, Child
• Interventions: Drug: Midazolam-hydroxyzine with 100% O2; Drug: Midazolam-hydroxyzine with 50% N2O/O2

• Registration Number: NCT03728894
• Lead Sponsor: Tishreen University

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-02
• Study Start: 2018-11-17
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-05
• Primary Completion: 2019-01-06
• Study Completion: 2019-01-06
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A: Midazolam-hydroxyzine with 100% O2	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.
Midazolam-hydroxyzine with 50% N2O/ O2	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.

Primary Outcome Measures

Name	Time	Method
Behavior improvement on the modified Houpt behavioral rating scale	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	Behavior assessment improvement related to the addition of N2O/O2 to the combination midazolam-hydroxyzine.

Trial Locations

Locations (1)

Tishreen University; 🇸🇾 Latakia, Syrian Arab Republic