Intranasal sedation and Nitrous oxide-Oxygen inhalation sedation for 5-10 year old Anxious Children Undergoing Dental Treatment
Phase 2
Completed
- Conditions
- Health Condition 1: K040- Pulpitis
- Registration Number
- CTRI/2024/01/061815
- Lead Sponsor
- Saveetha Dental College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 62
Inclusion Criteria
ASA 1
Frankl behaviour rating 1
Pulpotomy
Pulpectomy
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method evel of sedationTimepoint: Before start of treatment , After administration of local anaesthetic , during biomechanical preparation , after completion of treatment.
- Secondary Outcome Measures
Name Time Method 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)