Trials / Completed
CompletedNCT03827408
Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment
Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment: A Randomized Clinical Trial
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Nourhan M.Aly · Academic / Other
- Sex
- All
- Age
- 4 Years – 6 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment.
Detailed description
Dental anxiety and fear related behaviors are global problems in Pediatric Dentistry. Preschoolers represent a dental behavior management problem and there is always a debate over the best behavioral management technique for preschoolers undergoing dental treatment. Moderate sedation is considered as an acceptable option. Children who need treatment under local anesthesia, for thirty minutes will be included in the study. A total of 72 uncooperative pediatric dental patients, of age range 4-6 years, will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Midazolam group (MDZ) | IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland |
| DRUG | Dexmedetomidine group (DEX) | IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA. |
| DRUG | Combination of Midazolam and Dexmedetomidine (MDZ/DEX) | Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.( |
Timeline
- Start date
- 2017-11-27
- Primary completion
- 2019-08-29
- Completion
- 2019-12-22
- First posted
- 2019-02-01
- Last updated
- 2020-01-22
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT03827408. Inclusion in this directory is not an endorsement.