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Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Patients

NCT04608734 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-10-29

No results posted yet for this study

Summary

Purpose of this study was to assess the efficacy of aerosolized midazolam, introduced through buccal versus intranasal mucosa in managing uncooperative children undergoing dental treatment.

Conditions

  • Dental Anxiety

Interventions

DRUG

Buccal midazolam

The drug was sprayed in the buccal vestibule across the area between the primary first and second molars in all four quadrants to maximize the absorption through wide area of the buccal mucosa.

DRUG

Intranasal midazolam

Half of the dose was sprayed in the right nostril and the other half in the left nostril to double the absorptive surface area by short and quick puffs.

Sponsors & Collaborators

  • Alexandria University

    collaborator OTHER

  • Nourhan M.Aly

    lead OTHER

Principal Investigators

  • Yousr N Mowafy, M.Sc · Faculty of Dentistry, Alexandria University, Egypt

  • Nadia A Wahba, PhD · Faculty of Dentistry, Alexandria University, Egypt

  • Tamer M Ghoneim, PhD · Faculty of Medicine, Alexandria University, Egypt

  • Ghada M Mahmoud, PhD · Faculty of Dentistry, University of Modern Sciences and Arts, Egypt.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-10
Primary Completion
2016-06-13
Completion
2016-06-25

Countries

  • Egypt

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 NCT04608734 on ClinicalTrials.gov