Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment

Phase 2

Completed

• Conditions: Dental Anxiety
• Interventions: Drug: Midazolam group (MDZ); Drug: Dexmedetomidine group (DEX); Drug: Combination of Midazolam and Dexmedetomidine (MDZ/DEX)

• Registration Number: NCT03827408
• Lead Sponsor: Nourhan M.Aly

Brief 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.

Study Timeline

• Study Start: 2017-11-27
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Primary Completion: 2019-08-29
• Study Completion: 2019-12-22
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Age range 4-6 years
• Frankl scale score 2.
• ASA I or II physical status.
• Dental intervention under local anesthesia not requiring more than 30 minutes.
• No previous dental experience.
• Parent/guardian"s written consent.

Exclusion Criteria

• Dental treatment indicated under general anesthesia.
• Presence of facial deformities.
• History of neurological or cognitive alterations.
• Mouth breathers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midazolam group (MDZ)	Midazolam group (MDZ)	Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.5 mg/kg Midazolam.
Dexmedetomidine group (DEX)	Dexmedetomidine group (DEX)	Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 5µg/kg Dexmedetomidine.
Combination of Midazolam and Dexmedetomidine (MDZ/DEX)	Combination of Midazolam and Dexmedetomidine (MDZ/DEX)	Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.

Primary Outcome Measures

Name	Time	Method
Post-operative effects of the sedation	immediately after completion of the dental treatment procedures.	This will be assessed according to Modified Vernon et al.
Analgo-sedative effect of each drug	during the sedation procedure (from its onset till meeting discharge criteria)	The duration of sedation: defined as the onset of satisfactory sedation until the time of meeting discharge criteria according to the American Academy of Pediatric Dentistry.
Facemask acceptance during drug delivery	during the sedation procedure	It will be evaluated according to Zanaty \& Metainy as: poor (terrified, crying and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured) or excellent (unafraid, cooperative and accepts mask readily)
Effect of sedation on children's future behavior	after one week in the follow-up session	Each child's behavior will be reassessed in the follow-up sessions and compared to that at baseline (before dental treatment) using Frankl scale (ranges from 0-4)
The 'ease of treatment completion' sing separate five-point scales.	immediately after completion of the dental treatment procedures.	This will be measured using separate five-point scales according to Surendar et al: Score 5 indicates an excellent quiet and cooperative child while score 1 indicates Prohibitive active resistance and crying; treatment cannot be rendered.
Analgo-sedative effect of each drug.	during the sedation procedure (from its onset till meeting discharge criteria)	Assessment of the most common procedural side effects such as (hypoxia, respiratory depression, agitation, arrhythmia, bradycardia, hypotension or hypertension, shivering, nausea and vomiting) will be recorded.
Amnesic effect of sedative agents.	immediately after completion of the dental treatment procedures.	Anterograde amnesia: will be assessed according to a modification of Bulach et al.
Hemodynamic response of sedative agents.	during the sedation procedure (from its onset till meeting discharge criteria)	Vital sign: Oxygen saturation will be monitored using an oximeter

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt