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

A comparative evaluation of sedative effect of intravenous ketamine/midazolam with ketamine/dexmedetomidine combination in 2-6 years old uncooperative pediatric dental patient

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230629058616N1
Enrollment
24
Registered
2023-07-25
Start date
2023-08-06
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

?Anxiety. Anxiety disorder due to known physiological condition

Interventions

Intervention 1: Intervention group: In group AB, combination of Dexmedetomidine (dose: 1µgr/kg) and ketamine (dose: 2 mg/kg) will be injected in the intervention phase and the first session of dental

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Masoud Seyed Ahadi

Shahid Beheshti University of Medical Sciences

dr.masoud.ahadi@gmail.com+98 21 2241 3897

Outcome results

None listed

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