Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care

Status Completed

Clinical Trial 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.

Clinical Trial Description

- Prospective, parallel design - Study and control group: 100 healthy children (ASA 1), ages: 2-6 years, uncooperative (Frankl 1-2), 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. - Randomization: At the first appointment the subjects will assigned randomly to receive oral midazolam or nasal midazolam; - Sedation: oral midazolam dose is 0.5mg/kg. Nasal midazolam dose is 0.2mg/kg. During treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. - Acceptability of the medication: compliance in taking the medication will be assessed and recorded as: willingly, coaxed, forced, or failed (not administered). - Behavior during dental treatment: Houpt scale measures behavior by rating sleep, movement, crying and overall behavior. The degree of alertness, movement and crying will be assessed before, during (every 5 min) and after the operative procedure. The rating will be done by one observer blind to the route of administration. This blind observer will also monitor the pulse and oxygen saturation. ;

Study Design

Related Conditions & MeSH terms

Conscious Sedation

Clinical Trial Details

NCT number	NCT02679781
Study type	Interventional
Source	Hadassah Medical Organization
Contact
Status	Completed
Phase	N/A
Start date	March 28, 2017
Completion date	December 15, 2020

View Details

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