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Comparing sedation effect of IV Ketamine with Fentanyl in pediatric dentistry

Phase 3
Conditions
ncooperative Pediatric Dental patient.
Generalized anxiety disorder
F41.1
Registration Number
IRCT20140106016106N6
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
38
Inclusion Criteria

Uncooperative Children aged 2 to 6 years (definitely negative in Frankl scale)
Patients needing at least 2 similar dental treatment sessions with local anesthesia.
pediatric patients in ASA I

Exclusion Criteria

Patients with any Systemic disease,
Patients having common cold at treating session
any contraindication for the use of drugs or sedation

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Induced sufficient sedation for delivering dental treatment. Timepoint: baseline, at IV sedation, every 15 min afterwards, at discharge. Method of measurement: Recording data in prepared forms in addition to a questionnaire.
Secondary Outcome Measures
NameTimeMethod
Adverse effects of the sedative drugs used. Timepoint: at discharge and 24 hours later. Method of measurement: Questionnaire and by phone.
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