Oral Sedation With and Without Nitrous Oxide

Tishreen University

Status and phase: Completed; Phase 3

Conditions: Behavior, Child

Treatments: Drug: Midazolam-hydroxyzine with 50% N2O/O2; Drug: Midazolam-hydroxyzine with 100% O2

Study type: Interventional

Funder types: Other

Identifiers

NCT03728894

Tishreen-sedation

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 6 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

A: Midazolam-hydroxyzine with 100% O2

Active Comparator group

Description:

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.

Treatment:

Drug: Midazolam-hydroxyzine with 100% O2

Midazolam-hydroxyzine with 50% N2O/ O2

Experimental group

Description:

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.

Treatment:

Drug: Midazolam-hydroxyzine with 50% N2O/O2