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

Nourhan M.Aly

Status and phase: Completed; Phase 3; Phase 2

Conditions: Moderate Sedation; Anti-anxiety Agents

Treatments: Drug: Sublingual Dexmedetomidine; Drug: Intranasal Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04237532

Sublingual vs intranasal DEX

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 5 to 7 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Intranasal Dexmedetomidine

Experimental group

Treatment:

Drug: Intranasal Dexmedetomidine

Sublingual Dexmedetomidine

Experimental group

Treatment:

Drug: Sublingual Dexmedetomidine