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Clinical Trials/NCT05883150
NCT05883150
Completed
Phase 2

Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment: A Randomized Clinical Trial

Nourhan M.Aly1 site in 1 country68 target enrollmentNovember 10, 2022
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ConditionsDental Sedation
InterventionsNebulized MidazolamIntranasal Midazolam

Overview

Phase
Phase 2
Intervention
Nebulized Midazolam
Conditions
Dental Sedation
Sponsor
Nourhan M.Aly
Enrollment
68
Locations
1
Primary Endpoint
Behavior rating
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The aim of the current study is to compare the effect of intranasal versus nebulized route of administration of midazolam as moderate sedative agents in preschoolers undergoing dental treatment.

Registry
clinicaltrials.gov
Start Date
November 10, 2022
End Date
August 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nourhan M.Aly
Responsible Party
Sponsor Investigator
Principal Investigator

Nourhan M.Aly

Assistant Lecturer of Dental Public Health

University of Alexandria

Eligibility Criteria

Inclusion Criteria

  • •Frankl scale score
  • •ASA I or II physical status.
  • •Dental intervention under local anesthesia not requiring more than 30 minutes.
  • •No previous dental experience.
  • •Parent/guardian's written consent.

Exclusion Criteria

  • •Dental treatment indicated under general anesthesia.
  • •Presence of facial or nasal deformities.
  • •History of neurological or cognitive alterations.
  • •Mouth breathers

Arms & Interventions

Nebulized Midazolam

Intervention: Nebulized Midazolam

Intranasal Midazolam

Intervention: Intranasal Midazolam

Outcomes

Primary Outcomes

Behavior rating

Time Frame: throughout the sedation session

This will be recorded using the Modified Houpt scale for behavior rating; Sleep, head/oral resistance, crying and overall behavior will be scored on a 6-point scale ranging from 1-6 with higher scores indicating better behavior

Secondary Outcomes

  • Level of sedation(during the sedation procedure (after drug administration until reaching satisfactory sedation))
  • Onset of sedation(during the sedation procedure (after drug administration until reaching satisfactory sedation))

Study Sites (1)

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