Comparative Evaluation of Two Sedatives in Pediatric Dental Procedure - A Randomized Clinical Trial

Phase 2/3

Completed

• Conditions: Pulpitis,

• Registration Number: CTRI/2022/02/040572
• Lead Sponsor: Narsinhbhai Patel Dental College and Hospital

Brief Summary

This study is randomized controlled trial to compare  the effectives of  Midazolam and Dexmedetomidine as Sedative and Anxiolytic agent during dental procedures among 4 to 9 year old children utilizing split mouth technique. It would be conducted in Department of Pediatric and Preventive Dentistry at Narsinhbhai Patel Dental College & Hospital Visnagar Gujarat India. The primary outcome measures will be Dexmedetomidine is a better anxiolytic and sedative agent than Midazolam  in children during dental procedures. The secondary outcome measures will be Intranasal Dexmedetomidine is more effective than Intranasal Midazolam.

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Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-10
• Study Completion: 2022-11-30
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients undergoing treatment for the first time.
• Patient who exhibit anxious behavior in Frankel behavior rating scale ( score 1 & 2) Requiring two dental procedures under local anaesthesia.

Exclusion Criteria

• Patients who do not exhibit anxious behaviour on baseline anxiety scale.
• Patients with any systemic disease or drug allergy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dexmedetomidine is a better anxiolytic and sedative agent than Midazolam	Baseline, During procedure (45 mins) and After procedure (2 hours).

Secondary Outcome Measures

Name	Time	Method
Intranasal Dexmedetomidine is more effective than Midazolam	Baseline, During procedure (45 mins) and After procedure (2 hours)

Trial Locations

Locations (1)

Narsinhbhai Patel Dental College and Hospital; 🇮🇳 Mahesana, GUJARAT, India

Narsinhbhai Patel Dental College and Hospital

🇮🇳Mahesana, GUJARAT, India

DR KAVYA SHAH

Principal investigator

7708535361

kavshah04@gmail.com