Evaluation of sedative effect of ketamine/midazolam with ketamine/dexmedetomidine in dental uncooperative childre

Phase 3

Recruiting

• Conditions: ?Anxiety.; Anxiety disorder due to known physiological condition; F06.4

• Registration Number: IRCT20230629058616N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Non-cooperative children aged 2-6 years (completely negative based on the Frankel scale rating)
The patient should be in ASA I group.
The patient needs to perform at least 2 sessions of similar dental work and needs injection.

Exclusion Criteria

Do not have a systemic disease.
Do not be in ASA1, ASA2 groups.
.Do not have contraindications to receive sedatives.
During sedation, they should not have symptoms of cold or respiratory tract obstruction

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The level of child's cooperation. Timepoint: Before dental treatment, during dental treatment and after dental treatment. Method of measurement: Observation and based on Houpt Behavioral Scale.;Heart Rate. Timepoint: Before dental treatment, during dental treatment and after dental treatment. Method of measurement: Pulse oximeter device.;Atrial oxygen saturation or Spo2. Timepoint: Before dental treatment, during dental treatment and after dental treatment. Method of measurement: Pulse oximeter device.