Intranasal sedation and Nitrous oxide-Oxygen inhalation sedation for 5-10 year old Anxious Children Undergoing Dental Treatment

Comparative Evaluation of Intranasal Dexmedetomidine-Ketamine, Ketamine-Midazolam and Nitrous oxide-Oxygen inhalation for conscious sedation of 5-10 year old Anxious Children Undergoing Dental Treatment: A Randomised Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061815

Enrollment

Registered

2024-01-24

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Intranasal dexmedetomidine-ketamine: Intranasal drug combination delivered to anxious children requiring pulp therapy before start of treatment using mucosal atomisation device to check

Eligibility

Inclusion criteria

Inclusion criteria: ASA 1 Frankl behaviour rating 1 Pulpotomy Pulpectomy

Exclusion criteria

Exclusion criteria: Not cleared by anaesthetist for sedation Any known allergy,hypersensitive reaction Recent administration of erythromycin,anticonvulsant - as they may interfere with pharmacokinetics of midazolam,ketamine

Design outcomes

Primary

Measure	Time frame
Level of sedationTimepoint: Before start of treatment , After administration of local anaesthetic , during biomechanical preparation , after completion of treatment.	—

Secondary

Measure	Time frame
Behaviour ratingTimepoint: Before start of treatment , After administration of local anaesthetic , during biomechanical preparation , after completion of treatment.;Oxygen SaturationTimepoint: At start ,10 minutes, 20 minutes, 30 minutes , 40 minutes , 50 minutes, 60 minutes, 70 minutes , 80 minutes , at time of discharge;Pulse rate (in bpm)Timepoint: At start ,10 minutes, 20 minutes, 30 minutes , 40 minutes , 50 minutes, 60 minutes, 70 minutes , 80 minutes , at time of discharge;total sedation timeTimepoint: from onset of sedation to recovery (in minutes)	—

Measure

Time frame

Behaviour ratingTimepoint: Before start of treatment , After administration of local anaesthetic , during biomechanical preparation , after completion of treatment.;Oxygen SaturationTimepoint: At start ,10 minutes, 20 minutes, 30 minutes , 40 minutes , 50 minutes, 60 minutes, 70 minutes , 80 minutes , at time of discharge;Pulse rate (in bpm)Timepoint: At start ,10 minutes, 20 minutes, 30 minutes , 40 minutes , 50 minutes, 60 minutes, 70 minutes , 80 minutes , at time of discharge;total sedation timeTimepoint: from onset of sedation to recovery (in minutes)

—

Countries

India

Contacts

Public ContactDrGanesh Jeevanandan

Saveetha Dental College and Hospitals

helloganz@gmail.com9884293869

Outcome results

None listed

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