Clinical trial NCT04237532: Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment
Official title: Effectiveness of Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Anti-anxiety Agents
Moderate Sedation
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-01-23
Enrollment: 42
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study will be randomized controlled clinical trial with a cross over design where each patient will serve as his/her own control
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptance of drug administration
timeFrame: during the sedation procedure
measure: Level of Sedation
timeFrame: during the sedation procedure
measure: Anxiety level
timeFrame: during the sedation procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: May Shaat, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Niveen Bakry, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Dalia M Talaat, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Ahmed M El-Shafei, PhD
role: STUDY_DIRECTOR
References:
citation: al-Rakaf H, Bello LL, Turkustani A, Adenubi JO. Intra-nasal midazolam in conscious sedation of young paediatric dental patients. Int J Paediatr Dent. 2001 Jan;11(1):33-40. doi: 10.1046/j.1365-263x.2001.00237.x.
citation: Wilton NC, Leigh J, Rosen DR, Pandit UA. Preanesthetic sedation of preschool children using intranasal midazolam. Anesthesiology. 1988 Dec;69(6):972-5. doi: 10.1097/00000542-198812000-00032. No abstract available.
citation: Venham LL, Gaulin-Kremer E, Munster E, Bengston-Audia D, Cohan J. Interval rating scales for children's dental anxiety and uncooperative behavior. Pediatr Dent. 1980 Sep;2(3):195-202. No abstract available.