N/A N=70 Randomized Single-blind Treatment

Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care

Conscious Sedation

Bottom Line

View on ClinicalTrials.gov: NCT02679781 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2022

Primary outcome: Primary: Number of Participants Compliant With Oral or Nasal Midazolam Administration — 11; 4; 14; 18 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: oral midazolam (Drug); nasal midazolam (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Hadassah Medical Organization
Primary completion: Dec 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Compliant With Oral or Nasal Midazolam Administration	11; 4; 14; 18; 5; 8	—
SECONDARY Behavior During Dental Treatment	5.17; 4.80	—

Summary

The general objective of the study is to compare the efficacy of administering midazolam orally as syrup versus nasally with nasal atomizer. The specific objectives are to measure: 1) acceptability of the medication, 2) effect on behavior, 3) time of onset, 4) maximum working time.

Eligibility Criteria

Inclusion Criteria

healthy children (ASA 1), uncooperative (Frankl 1-210), that needs at least two similar dental treatments.

Exclusion Criteria

enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 = >75% airway obstruction), upper respiratory tract infection or nasal discharge.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02679781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.