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Comparing sedation effect of IV Ketamine with Fentanyl in pediatric dentistry

Comparing the sedative effect of IV Ketamine/Midazolam and Fentanyl/ Midazolam in uncooperative pediatric dental patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20140106016106N6
Enrollment
38
Registered
2020-11-25
Start date
2017-11-10
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

Uncooperative Pediatric Dental patient. Generalized anxiety disorder

Interventions

Intervention 1: Intervention group: Receiving the drug combination of 2 µg/kg Fentanyl, 0.2 mg/kg Midazolam, 0.1mg/kg Atropine IV at the case session scheduled using an IV line on top of oxygen line c

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Adverse effects of the sedative drugs used. Timepoint: at discharge and 24 hours later. Method of measurement: Questionnaire and by phone.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Ghassem Ansari

Shahid Beheshti University of Medical Sciences

drgansari@sbmu.ac.ir+98 21 2217 9421

Outcome results

None listed

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