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To make dental treatment easy without any anxiety for children with Intranasal spray of Dexmedetomidine/Midazolam

Comparative evaluation of effectiveness and acceptance of Intranasal Dexmedetomidine and Intranasal Midazolam in 5-8 years of children for sedation using Mucosal Atomizer Device (MAD) - A Randomized Controlled Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044010
Enrollment
48
Registered
2022-07-14
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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: Dexmedetomidine is an alpha 2 â??agonists, which is emerging as a promising choice for sedation in children. Dexmedetomidine was first approved by the Food a

Sponsors

KM Shah Dental College and Hospital Sumandeep Vidyapeeth
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Frankle behavior rating scale II children will be included. Children with ASA I or II health status Children with Pre anestehtic checkup will be done Preoperative heart rate of 55 to 100 beats per minute and Respiratory rate of 14 to 16 beats per minute. Maximum blood pressure reading of 140/100 mmHg. Patients who require LA administration for dental procedure.

Exclusion criteria

Exclusion criteria: 1. Patient without any systemic illness. 2. A history of allergy or intolerance to benzodiazepines. 3. An upper respiratory tract infection with nasal discharge or respiratory distress. 4. Parents not giving consent for the study.

Design outcomes

Primary

MeasureTime frame
1. Acceptance 2. Onset of sedation 3. Effectiveness 4. Dental axietyTimepoint: Pre-treatment and post-treatment

Secondary

MeasureTime frame
1. Blood pressure 2. Heart rate 3. Oxygen saturationTimepoint: pre treatment and post treatmnent

Countries

India

Contacts

Public ContactDr Bhavna Dave

K.M. Shah Dental College and Hospital

bhavnadave1964@gmail.com9998034036

Outcome results

None listed

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