Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment

Phase 2

Completed

• Conditions: Anti-anxiety Agents; Moderate Sedation
• Interventions: Drug: Sublingual Dexmedetomidine; Drug: Intranasal Dexmedetomidine

• Registration Number: NCT04237532
• Lead Sponsor: Nourhan M.Aly

Brief Summary

The aim of this study is to assess the efficacy of Dexmedetomidine drug either used sublingually or intranasally in managing healthy children during dental treatment

Detailed Description

Each child should fulfill the requirements of having a dental condition which needs treatment in two dental sessions, where each session should not exceed thirty minutes. At the first visit ,either sublingual or intranasal Dexmedetomidine will be used, while at the second visit the alternate route will be implemented in a cross-over design. At least one week interval between the two visits will be secured.

Study Timeline

• Study Start: 2019-08-27
• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-21
• Study First Posted: 2020-01-23
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Frankl behavior rating score 2.
• ASA I physical status.
• Dental intervention under local anesthesia not requiring more than 30 minutes.
• No previous dental experience.
• Parent/guardian written consent.

Exclusion Criteria

• Dental treatment indicated requiring general anesthesia.
• Mouth breathers.
• Patients with acute upper respiratory illness.
• Medically compromised patients.
• Cognitively impaired patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sublingual Dexmedetomidine	Sublingual Dexmedetomidine	-
Intranasal Dexmedetomidine	Intranasal Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Acceptance of drug administration	during the sedation procedure	Assessed by a 4 point Likert scale as follows: 1 (Good) the child accepted the drug without any refusal. 2 (fair) the child accepted the drug with some verbal resistance. 3 (poor) the child accepted the drug with some physical resistance. 4 (refused) the child refused but drug administration was possible after persuation.
Anxiety level	during the sedation procedure	Anxiety level during local anesthesia administration will be evaluated using Venham's clinical anxiety scale. 0: Relaxed child, 1: Uneasy, concerned, 2:Child appears scared, 3:Shows reluctance to enter situation, difficulty in correctly assessing situational threat, 4:Anxiety interferes with ability to assess situation.
Level of Sedation	during the sedation procedure	Time taken by both routes to reach the desired level of sedation using Wilton et al sedation scale and it is scored as follows: 1. Agitated: Clinging parent and/or crying. 2.Alert: Awake, but not clinging to parent may whimper but not crying. 3.Calm: Sitting or lying comfortably with eyes spontaneously open. 4.Drowsy: Sitting or lying comfortably with eyes spontaneously closing but responds to minor stimulation. 5. Asleep: Eyes closed, rousable, does not respond to minor stimulation.

Trial Locations

Locations (1)

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