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Evaluation of sedative effect of ketamine/fentanyl and midazolam/fentanyl on dental uncooperative children

Comparison of sedative effect of intravenous Ketamin/Fentanyl with Midazolam/Fentanyl on 2-6 years old uncooperative pediatric dental patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20140106016106N7
Enrollment
30
Registered
2020-11-30
Start date
2019-04-08
Completion date
Unknown
Last updated
2021-01-05

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 Fentanyl1-2 µg/kg micrograms , Midazolam 0.2 mg/kg , Atropine 0.1 mg/kg IV in one of the two randomize assigned and scheduled vis

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: Children aged 2 to 6 years Patients needing at least 2 similar dental treatment sessions ?treating each tooth requires local Anesthesia. pediatric patients in ASA I Uncooperative child definitely negative (in Frankl scale)

Exclusion criteria

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

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