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

Not yet recruiting

Conditions: Other and unspecified diseases ofpulp and periapical tissues,

Registration Number: CTRI/2025/06/088426

Lead Sponsor: Ashish Suresh

Brief Summary: This randomized controlled trial aims to evaluate and compare the effectiveness of oral midazolam premedication and audiovisual distraction (AVD) in reducing anxiety levels in children aged 2 to 6 years undergoing full mouth dental rehabilitation under general anesthesia. Children will be randomly assigned to two groups: one receiving oral midazolam premedication and the other receiving audiovisual distraction using animated videos before induction of anesthesia. Anxiety levels will be assessed preoperatively and postoperatively using validated behavioral and physiological measures. The study seeks to determine the more effective method for managing perioperative anxiety in pediatric dental patients to enhance overall patient experience and outcomes.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
stress levels measured using pulse rate, blood pressure and FLACC scores	Baseline and immediately post full mouth rehabilitation under general anesthesia

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Saveetha Dental College and Hospitals
🇮🇳
Thiruvallur, TAMIL NADU, India
Saveetha Dental College and Hospitals
🇮🇳Thiruvallur, TAMIL NADU, India
Dr Ashish Suresh
Principal investigator
9884927585
ashishamudha011@gmail.com