Sublingual Versus Intranasal Administration of Dexmedetomidine for Sedation of Children Undergoing Dental Treatment
NCT ID: NCT04237532
Last Updated: 2020-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
42 participants
INTERVENTIONAL
2019-08-27
2020-08-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Intranasal Dexmedetomidine
Intranasal Dexmedetomidine
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 Dexmedetomidine
Sublingual Dexmedetomidine
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.
Interventions
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Intranasal Dexmedetomidine
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 Dexmedetomidine
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 Criteria
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Inclusion Criteria
* 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
* Mouth breathers.
* Patients with acute upper respiratory illness.
* Medically compromised patients.
* Cognitively impaired patients.
5 Years
7 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Nourhan M.Aly
OTHER
Responsible Party
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Nourhan M.Aly
Instructor of Dental Public Health; Statistician
Principal Investigators
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May Shaat, BDS
Role: PRINCIPAL_INVESTIGATOR
Faculty of Dentistry, Alexandria University, Egypt
Niveen Bakry, PhD
Role: STUDY_CHAIR
Faculty of Dentistry, Alexandria University, Egypt
Dalia M Talaat, PhD
Role: STUDY_DIRECTOR
Faculty of Dentistry, Alexandria University, Egypt
Ahmed M El-Shafei, PhD
Role: STUDY_DIRECTOR
Faculty of Medicine, Alexandria University, Egypt
Locations
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Faculty of Dentistry, Alexandria University
Alexandria, , Egypt
Countries
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References
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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.
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.
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.
Other Identifiers
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Sublingual vs intranasal DEX
Identifier Type: -
Identifier Source: org_study_id