The effect of propofol and ketofol on restlessness after anesthesia in children

Comparative study of the effect of propofol and ketofol on restlessness after anesthesia in children aged 18-6 months under cleft palate surgery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200825048515N22

Enrollment

Registered

2021-01-20

Start date

2021-01-04

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

Cleft palate. Cleft palate, unspecified

Interventions

Intervention 1: First intervention group: Anesthesia induction is performed for patients by injecting 2 mg/kg propofol(Caspian Tamin Pharmaceutical), 2 µg/kg fentanyl(Caspian Tamin Pharmaceutical), an

Eligibility

Sex/Gender

All

Age

6 Months to 18 Months

Inclusion criteria

Inclusion criteria: Aged 6 to18 months Candidate for cleft palate surgery Classified as ASA I and II based on American Society of Anesthesiologists Classification Consent to participate in the study

Exclusion criteria

Exclusion criteria: Underlying diseases such as mitochondrial metabolic disorders and fat metabolism disorders History of convulsion Growth and development retardation

Design outcomes

Primary

Measure	Time frame
Delirium score. Timepoint: Immediately upon entering the recovery ward and 15, 30 and 45 minutes later in the recovery. Method of measurement: Pediatric Anesthesia Emergence Delirium Scale (PAED).;Pain score. Timepoint: 15, 30 and 45 minutes later in the recovery. Method of measurement: Behavioral scale derived from the Face, Leg, Activity, Cry, Consolability (FLACC).;Blood Pressure. Timepoint: Immediately after surgery, in the minutes of 15, 30, and 45 during surgery and immediately, 15, 30, and 45 minutes after recovery. Method of measurement: Monitoring device.;Heart rate. Timepoint: Immediately after surgery, in the minutes of 15, 30, and 45 during surgery and immediately, 15, 30, and 45 minutes after recovery. Method of measurement: Monitoring device.;Percentage of oxygen saturation. Timepoint: Immediately after surgery, in the minutes of 15, 30 and 45 during surgery and immediately, 15, 30 and 45 minutes after recovery. Method of measurement: Monitoring device.	—

Measure

Time frame

Delirium score. Timepoint: Immediately upon entering the recovery ward and 15, 30 and 45 minutes later in the recovery. Method of measurement: Pediatric Anesthesia Emergence Delirium Scale (PAED).;Pain score. Timepoint: 15, 30 and 45 minutes later in the recovery. Method of measurement: Behavioral scale derived from the Face, Leg, Activity, Cry, Consolability (FLACC).;Blood Pressure. Timepoint: Immediately after surgery, in the minutes of 15, 30, and 45 during surgery and immediately, 15, 30, and 45 minutes after recovery. Method of measurement: Monitoring device.;Heart rate. Timepoint: Immediately after surgery, in the minutes of 15, 30, and 45 during surgery and immediately, 15, 30, and 45 minutes after recovery. Method of measurement: Monitoring device.;Percentage of oxygen saturation. Timepoint: Immediately after surgery, in the minutes of 15, 30 and 45 during surgery and immediately, 15, 30 and 45 minutes after recovery. Method of measurement: Monitoring device.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Shafa

Esfahan University of Medical Sciences

shafa_amir@yahoo.com+98 31 3620 2020

Outcome results

None listed

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