Effectiveness of Buccal Administration of Dexmedetomidine - Ketamine Combination for Sedation of Pediatric Dental Patients (A Randomized Controlled Trial)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202105602764595

Enrollment

Registered

2021-05-27

Start date

2021-08-20

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Health

Interventions

Combination of Dexmedetomidine and Ketamine group

Dexmedetomidine group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients with an age ranging between 3-5 year old. • Frankl scale score 1 or 2 (Definitely Negative or Negative behavior) for whom all non-pharmacological behavior management failed to gain their compliance . • American Society of Anesthesiologist physical status of type I, II. • Dental intervention under local anesthesia not requiring more than 30 minutes. • Parent/guardian written consent.

Exclusion criteria

Exclusion criteria: • Patients who need extensive dental treatment requiring general anesthesia. • Patients with known allergy to ketamine or dexmedetomidine. • Medically compromised patients. • Cognitively impaired patients.

Design outcomes

Primary

Measure	Time frame
The primary outcome (drug effectiveness) will be assessed through: 1- Analgo-sedative effect of each drug -Onset of Sedation will be recorded in minutes. -The analgesic effect of the sedative drugs will be assessed during L.A. administration using ‘Face, Legs, Activity, Cry, Consolability’ scale “FLACC”. - Sedation level: Using Observer’s Assessment of Alertness/Sedation Scale. -The duration of sedation will be recorded in minutes. -Procedural side effects (hypoxia, agitation, bradycardia, hypotension, vomiting, etc) will be recorded during the procedure. 2- Behaviour response to drug delivered -Post-operative effects of the sedation will be assessed using child behavior questionnaire according to Modified Vernon et al. -Child’s behavior in the follow-up sessions will be reassessed and compared to that at baseline (before dental treatment) using Frankl scale.	—

Measure

Time frame

The primary outcome (drug effectiveness) will be assessed through: 1- Analgo-sedative effect of each drug -Onset of Sedation will be recorded in minutes. -The analgesic effect of the sedative drugs will be assessed during L.A. administration using ‘Face, Legs, Activity, Cry, Consolability’ scale “FLACC”. - Sedation level: Using Observer’s Assessment of Alertness/Sedation Scale. -The duration of sedation will be recorded in minutes. -Procedural side effects (hypoxia, agitation, bradycardia, hypotension, vomiting, etc) will be recorded during the procedure. 2- Behaviour response to drug delivered -Post-operative effects of the sedation will be assessed using child behavior questionnaire according to Modified Vernon et al. -Child’s behavior in the follow-up sessions will be reassessed and compared to that at baseline (before dental treatment) using Frankl scale.

—

Secondary

Measure	Time frame
- The ‘ease of treatment completion’ will be measured using separate five-point scales. - Amnesic effect of sedative agents. Anterograde amnesia: will be assessed according to a modification of Bulach et al. - Hemodynamic response of sedative agents will be recorded. (SBP, DBP, HR, and saO2). - Procedural-induced stress will be assessed in children by measuring salivary sIgA levels.	—

Countries

Egypt

Contacts

Public ContactHams Abdelrahman

Assistant lecturer of DPH

hamshamed14@gmail.com00201009374588

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026