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Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment

NCT04237532 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-10-29

No results posted yet for this study

Summary

The aim of this study is to assess the efficacy of Dexmedetomidine drug either used sublingually or intranasally in managing healthy children during dental treatment

Conditions

  • Anti-anxiety Agents
  • Moderate Sedation

Interventions

DRUG

Intranasal Dexmedetomidine

The mucosal atomizing device will be used intranasally where the sedative drug will be equally divided and sprayed into each nostril while the child semi reclined position.

DRUG

Sublingual Dexmedetomidine

The mucosal atomizing device will be used sublingually by asking the child to touch their maxillary incisor teeth with the tip of their tongue and instruct the child not to swallow the drug for 30 seconds.

Sponsors & Collaborators

  • Alexandria University

    collaborator OTHER

  • Nourhan M.Aly

    lead OTHER

Principal Investigators

  • May Shaat, BDS · Faculty of Dentistry, Alexandria University, Egypt

  • Niveen Bakry, PhD · Faculty of Dentistry, Alexandria University, Egypt

  • Dalia M Talaat, PhD · Faculty of Dentistry, Alexandria University, Egypt

  • Ahmed M El-Shafei, PhD · Faculty of Medicine, Alexandria University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-08-27
Primary Completion
2020-08-01
Completion
2020-08-10

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 NCT04237532 on ClinicalTrials.gov