NCT02679781

Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Conscious Sedation

Interventions

Type	Name	Description
DRUG	oral midazolam	administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
DRUG	nasal midazolam	administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.

Timeline

• Start date: 2017-03-28
• Primary completion: 2020-12-15
• Completion: 2020-12-15
• First posted: 2016-02-10
• Last updated: 2022-01-14
• Results posted: 2022-01-14

Locations

1 site across 1 country: Israel