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Oral Sedation With and Without Nitrous Oxide

NCT03728894 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-01-08

No results posted yet for this study

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.

Conditions

  • Behavior, Child

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • Tishreen University

    lead OTHER

Principal Investigators

  • Nabih Raslan, Dr · Tishreen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-17
Primary Completion
2019-01-06
Completion
2019-01-06

Countries

  • Syria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03728894 on ClinicalTrials.gov