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Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment

NCT03827408 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2020-01-22

No results posted yet for this study

Summary

The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment.

Conditions

  • Dental Anxiety

Interventions

DRUG

Midazolam group (MDZ)

IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland

DRUG

Dexmedetomidine group (DEX)

IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA.

DRUG

Combination of Midazolam and Dexmedetomidine (MDZ/DEX)

Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.(

Sponsors & Collaborators

  • Alexandria University

    collaborator OTHER

  • Nourhan M.Aly

    lead OTHER

Principal Investigators

  • Amira A El-Khatib, MSc · Alexandria University

  • Nadia A Wahba, PhD · Alexandria University

  • Karin ML Dowidar, PhD · Alexandria University

  • Tamer AM Ghoneim, PhD · Faculty of Medicine, Alexandria Univerity

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-27
Primary Completion
2019-08-29
Completion
2019-12-22

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 NCT03827408 on ClinicalTrials.gov