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

NCT04237532 | Completed Phase 2

• 1 other identifier: Sublingual vs intranasal DEX
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Anti-anxiety Agents; Moderate Sedation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  during the sedation procedure

Study Arms (2)

Intranasal Dexmedetomidine

EXPERIMENTAL

Drug: Intranasal Dexmedetomidine

Sublingual Dexmedetomidine

EXPERIMENTAL

Drug: Sublingual Dexmedetomidine

Interventions

Intranasal Dexmedetomidine DRUG

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.

Intranasal Dexmedetomidine

Sublingual Dexmedetomidine DRUG

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.

Sublingual Dexmedetomidine

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (3)

• 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.

  PMID: 11309871 BACKGROUND

• 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.

  PMID: 3195771 BACKGROUND

• 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.

  PMID: 6938934 BACKGROUND

Study Officials

• May Shaat, BDS

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Niveen Bakry, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Dalia M Talaat, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

• Ahmed M El-Shafei, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor of Dental Public Health; Statistician

Model Details: The study will be randomized controlled clinical trial with a cross over design where each patient will serve as his/her own control

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 23, 2020
• Study Start: August 27, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 10, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-10

Locations

EG (1)