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Comparing Midazolam by two Different Routes for Sedation in Anxious children during Local Anesthesia

Comparative Evaluation of Oral Midazolam and Buccal Midazolam for Procedural Sedation in Anxious children during Local Anesthesia administration: A Cross over Clinical trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067796
Enrollment
30
Registered
2024-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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: Midazolam oral (Mezolam, Midazolam Injection I.P): Oral Midazolam (0.5 mg/kg) will be give with concentrated Glucon-D (Mezolam 5mg/1ml by Neon Pharmaceuticals) will be given orally befo

Sponsors

ITS Dental College Hospital and Research Centre Greater Noida
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Uncooperative children (Frankl’s Behavior Rating Scale Grade I and II) aged 4-8 years in whom routine behavior modification techniques have not been effective. 2.Healthy children (ASA I). 3.Children who require procedures (e.g. vital pulp therapy, extraction or restoration) to be done under local anesthesia. 4.Parents of children who are willing to give consent for their child.

Exclusion criteria

Exclusion criteria: 1.Children with upper respiratory tract infections, any nasal pathology and any known allergy. 2.Children with sensitivity or any other form of reaction to benzodiazepines and Â2 adrenoceptor agonists. 3.Children with mental retardation, who are on anticonvulsant therapy or other sedative medications.

Design outcomes

Primary

MeasureTime frame
Behaviour, ease of administration of drug, score criteria for acceptance of drug, sedation level, onset of sedation will be assessed.Timepoint: 10,20,30,40,50 and 60 minutes

Secondary

MeasureTime frame
Vitals, recovery and discharge criteria will be assessedTimepoint: 10,20,30,40,50 and 60 minutes

Countries

India

Contacts

Public ContactDr Mriganka Kumar Phukan

ITS Dental College Hospital and Research Centre

hod.pedo.gn@its.edu.in8588854190

Outcome results

None listed

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