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

Nourhan M.Aly42 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anti-anxiety Agents Moderate Sedation

Interventions

Intranasal DexmedetomidineDRUG

The mucosal atomizing device will be used intranasally where the sedative drug will be equally divided and sprayed into each nostril while the child semi reclined position.

Sublingual DexmedetomidineDRUG

The mucosal atomizing device will be used sublingually by asking the child to touch their maxillary incisor teeth with the tip of their tongue and instruct the child not to swallow the drug for 30 seconds.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 7 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

Acceptance of drug administration

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.

Time frame: during the sedation procedure

Level of Sedation

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.

Time frame: during the sedation procedure

Anxiety level

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.

Time frame: during the sedation procedure

Data from ClinicalTrials.gov

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