N/A
Completed N=70
Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care
Conscious Sedation
Source: ClinicalTrials.gov NCT02679781 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Number of Participants Compliant With Oral or Nasal Midazolam Administration — 11; 4; 14; 18 Participants
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.
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 | — |
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.
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. Informational only — not medical advice.