Health Condition 1: K029- Dental caries, unspecified
Conditions
Interventions
Intervention1: Dexmedetomidine (intranasal) + Nitrous oxide: A combination of intranasal midazolam (0.1 0.2 mg/kg) administered using a mucosal atomization device (MAD) and inhaled nitrous oxide (up t
Sponsors
AIIMS MANGALAGIRI
Eligibility
Inclusion criteria
Inclusion criteria: 1.Behavioural category: Frankl Behaviour Rating Scale negative and definitely negative. 2.Patient s whose approval has been granted by anaesthesiologist for the proposed procedure. 3. Patient classified as American Society of Anaesthesiologist (ASA) physical status classification I and II. 4. Patients requiring a minimum of three dental procedures including deep restorations, pulpectomy, pulpotomy or extractions during the study period
Exclusion criteria
Exclusion criteria: 1. Patients with conditions that may cause severe airway obstruction (e.g., adenoid hyperplasia, nasal septum issues, enlarged turbinates, nasal polyps) , with upper or lower respiratory tract infections, mouth breather or with chronic pulmonary disease. 2. 3. 4. Patient with history of middle ear surgery, otitis media or infections.10 Individuals exhibiting severe cognitive deficits. Patients who have recently used medications such as bleomycin sulfate 10,erythromycin or anticonvulsants that may impact the pharmacokinetics of the drugs to be used. 5. Patient with any autoimmune disease or immunosuppressive therapy.10 6. Patient with methionine synthase deficiency, methylene tetrahydrofolate reductase deficiency or vitamin B12 deficiency10 . 7. Surgery which involves anterior surface of maxilla ( e.g.: extraction of an impacted tooth, 8. removal of odontomes and cysts ) Any prior diagnosis of systemic diseases that may affect sedation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate sedation effectiveness using standard behavioral scales including Wood Mask Acceptance Scale, Frankl Behaviour Rating Scale, Houpt Behaviour Scale and AAPD Sedation Effectiveness Rank.Timepoint: Pre-sedation, during sedation, and immediate post-sedation | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess physiological parameters (heart rate, blood pressure, oxygen saturation) and incidence of adverse effects (sneezing, vomiting, respiratory distress, etc.) across all three sedation protocolTimepoint: Baseline (pre-sedation) During procedure Recovery period (immediate post-procedure) | — |
Countries
India
Contacts
Public ContactAswathi Venugopal
AIIMS MANGALAGIRI
Outcome results
None listed