Comparative evaluation of oral sedative agent in children undergoing pediatric dental treatment procedure.

Comparative evaluation of oral and intranasal dexmedetomidine as a sedative agent in 6-11 years old children undergoing pediatric dental treatment procedure a double blind, randomised controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/041136

Enrollment

Registered

2022-03-16

Start date

Unknown

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: intranasal Dexmedetomidine: 2.0 ug/kg intranasal Dexmedetomidine as drops using insulin syringe (without needle) the half of total volume is administered in each nostrils in semi- recum

Eligibility

Inclusion criteria

Inclusion criteria: 1. Uncooperative and scored 1 or 2 on the Frankel scale. 2. ASA - grade 1. 3. No medical history of neurologic or cognitive alterations. 4. Children with dental caries only .

Exclusion criteria

Exclusion criteria: 1. Known allergy to Dexmedetomidine. 2. Upper respiratory tract infection with nasal discharge. 3. Any Systemic illness 4. Dental conditions which require local anesthetic injection. 5. Complaint of pain. 6. Decay involving the pulp.

Design outcomes

Primary

Measure	Time frame
1. Onset of sedation 2. Duration of sedation 3. Working time 4. Recovery time 5. Depth of sedation 6. Acceptance of the drug 7. Behavior changes 8. Adverse effects 9. Overall success.Timepoint: 1. Onset of sedation: 30- 45 minutes 2. Duration of sedation: 2-4hours 3. Working time- 20-60 minutes 4. Recovery time: 60-120 minutes 5. Depth of sedation 6. Acceptance of the drug 7. Behavior changes 8. Adverse effects - up to 24 hours 9. Overall success.	—

Measure

Time frame

1. Onset of sedation 2. Duration of sedation 3. Working time 4. Recovery time 5. Depth of sedation 6. Acceptance of the drug 7. Behavior changes 8. Adverse effects 9. Overall success.Timepoint: 1. Onset of sedation: 30- 45 minutes 2. Duration of sedation: 2-4hours 3. Working time- 20-60 minutes 4. Recovery time: 60-120 minutes 5. Depth of sedation 6. Acceptance of the drug 7. Behavior changes 8. Adverse effects - up to 24 hours 9. Overall success.

—

Secondary

Measure	Time frame
not applicableTimepoint: not applicable	—

Countries

India

Contacts

Public ContactDrPooja V R

SRM Kattankulathur dental college and hospital.

kavithar2@srmist.edu.in9884837586

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026