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checking whether a drug called midazolam or the use of entertaining audio video would effectively reduce the childs stress before and after undergoing treatment in full anesthesia

Comparison of Midazolam Premedication , Audiovisual Distraction and combination in Reducing Pre- and Post-Operative Anxiety in Children Aged 3 6 Years Undergoing Full Mouth Dental Rehabilitation Under General Anesthesia. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088426
Enrollment
60
Registered
2025-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: K049- Other and unspecified diseases ofpulp and periapical tissues

Interventions

Intervention1: Midazolam Premedication: 0.5mg per Kg in oral route, 30 minutes before the procedure Control Intervention1: Audio video distraction: Animated videos of the childs favourite show to dist

Sponsors

Ashish Suresh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children who are between 2 to 6 years old 2.Healthy children (ASA II) 3.Body weight within the Inter Quartile Range (IQR) for this age group as defined by the Centers for Disease Control and Prevention 4.No history of adverse reaction to anesthetic drugs or other medication 5.Children with no Physical or Cognitive disablities 6.Patient reporting to the dental operatory for the first time to minimize behavioural bias 7.Children requiring pulp therapy procedures

Exclusion criteria

Exclusion criteria: 1.Allergy to lidocaine anesthetic drugs or midazolam 2.Local anesthetic or other drug administered within the week before the session in which they participated 3.Highly symptomatic teeth 4.Localised Lesion at the site of injection 5.Children with prior dental experience 6.Patients with developmental or linguistic disorders who cannot communicate properly 7.Children with medications which affect behaviour 8.Medically and systematically compromised patients 9.Patients with cognitive impairments or special needs

Design outcomes

Primary

MeasureTime frame
stress levels measured using pulse rate, blood pressure and FLACC scoresTimepoint: Baseline and immediately post full mouth rehabilitation under general anesthesia

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDeepa Gurunathan

Saveetha Dental College and Hospitals

deepag@saveetha.com9994619386

Outcome results

None listed

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