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"Sedation with Fentanyl & Ketamin in pediatric dentistry"

Effect of Fentanyl addition to Ketamin, Midazolam mixture in intravenous sedation of 2 to 6 years old uncooperative children

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20140106016106N5
Enrollment
32
Registered
2018-08-05
Start date
2017-09-23
Completion date
Unknown
Last updated
2018-09-11

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

Conditions

Intravenous sedation in dentistry.

Interventions

Intervention 1: Intervention group 1: In 1st session oral Midazolam suspension premedication (0.5 mg/kg) is administered half an hour before IV Ketamin (up to 2 mg/kg), 1 mg Midazolam and 0.1 mg Atrop

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: 2 to 6 year old non-cooperative children (definitely negative at Frankl's scale) that at least two pediatric dentist have evaluated their lack of co-operation At least 2 same treatment sessions with local anesthetics are required The patient is in the ASA I group.

Exclusion criteria

Exclusion criteria: Patients with systemic diseases Any contraindication in drug use Any contraindication in sedation

Design outcomes

Primary

MeasureTime frame
O2 Saturation of blood. Timepoint: Recording O2 saturation at the baseline, anesthesia injection, 15 and 30 minutes after the start of treatment and at discharge of the patient. Method of measurement: Alborz Saadat hospital monitoring device.;Heart rate. Timepoint: Recording Heart rate at the baseline, anesthesia injection, 15 and 30 minutes after the start of treatment and at discharge of the patient. Method of measurement: Alborz Saadat hospital monitoring device.;Blood pressure. Timepoint: Recording Blood pressure at the baseline, anesthesia injection, 15 and 30 minutes after the start of treatment and at discharge of the patient. Method of measurement: Alborz Saadat hospital monitoring device.;Respiratory rate. Timepoint: Recording respiratory rate at the baseline, anesthesia injection, 15 and 30 minutes after the start of treatment and at discharge of the patient. Method of measurement: Alborz Saadat hospital monitoring device.;Sleepiness scale. Timepoint: Anesthesia injection, 15 and 30 minutes after the start of treatment. Method of measurement: Houpt sedation scale.;Crying scale. Timepoint: Anesthesia injection, 15 and 30 minutes after the start of treatment. Method of measurement: Houpt sedation scale.;Motion scale. Timepoint: Anesthesia injection, 15 and 30 minutes after the start of treatment. Method of measurement: Houpt sedation scale.;Overall behavior. Timepoint: Anesthesia injection, 15 and 30 minutes after the start of treatment. Method of measurement: Houpt sedation scale.

Secondary

MeasureTime frame
Parents' opinion about sedation session. Timepoint: 24 hours after treatment. Method of measurement: Questionaire.;Clinician opinion about treatment session. Timepoint: At the end of treatment session. Method of measurement: Questionaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGhassem Ansari

Shahid Beheshti University of Medical Sciences

drgansari@yahoo.com+98 21 2225 5958

Outcome results

None listed

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