The effect of Dexmedethomidine on post operative agitation in children undergoing oral surgeries

Efficacy of intravenous infusion of Dexmedetomidine in the first ten minutes of surgery in comparison with last ten minutes of surgery on post operative agitation in 9 to 96 months aged children undergoing oral surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016122031497N1

Enrollment

Registered

2017-03-31

Start date

2016-11-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Agitation. Restlessness and agitation

Interventions

Intervention 1: Dexmedetomidine, 1 µg/kg intravenous infusion, first ten minutes of surgery. Intervention 2: Dexmedetomidine, 1 µg/kg intravenous infusion, last ten minutes of surgery.

Treatment - Drugs

Dexmedetomidine, 1 µg/kg intravenous infusion, first ten minutes of surgery

Dexmedetomidine, 1 µg/kg intravenous infusion, last ten minutes of surgery

Eligibility

Sex/Gender

All

Age

9 Months to 8 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with class 1 according to the American Society of Anesthesiology (ASA) scoring criteria; Age of 9 months to 96 months Exclusion criteria: Parental disagreement

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Agitation. Timepoint: ?After surgery in the recovery room. Method of measurement: Ramsay sedation scale.	—

Secondary

Measure	Time frame
Mean arterial blood pressure. Timepoint: Every five minutes. Method of measurement: Millimeter of mercury announced by vital sign monitoring system.;Heart rate. Timepoint: Every five minutes. Method of measurement: Heart rate announced by vital sign monitoring system.;Anesthesia time. Timepoint: Start of induction of anesthesia until extubation. Method of measurement: Minute.;Surgical time. Timepoint: Since the start of the operation until the end of the operation. Method of measurement: Minute.;Extubation time. Timepoint: After discontinuation of anesthetic gas until extubation. Method of measurement: Minute.;Recovery time. Timepoint: From entrance of patient to recovery room until discharge from recovery room. Method of measurement: Minute.;FLACC ( Face, Legs, Activity, Cry, Consolability) pain scale at recovery. Timepoint: After surgery in the recovery room. Method of measurement: FLACC (Face, Legs, Activity, Cry, Consolability) scale.	—

Measure

Time frame

Mean arterial blood pressure. Timepoint: Every five minutes. Method of measurement: Millimeter of mercury announced by vital sign monitoring system.;Heart rate. Timepoint: Every five minutes. Method of measurement: Heart rate announced by vital sign monitoring system.;Anesthesia time. Timepoint: Start of induction of anesthesia until extubation. Method of measurement: Minute.;Surgical time. Timepoint: Since the start of the operation until the end of the operation. Method of measurement: Minute.;Extubation time. Timepoint: After discontinuation of anesthetic gas until extubation. Method of measurement: Minute.;Recovery time. Timepoint: From entrance of patient to recovery room until discharge from recovery room. Method of measurement: Minute.;FLACC ( Face, Legs, Activity, Cry, Consolability) pain scale at recovery. Timepoint: After surgery in the recovery room. Method of measurement: FLACC (Face, Legs, Activity, Cry, Consolability) scale.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfsaneh Sadeghi

Shahid Beheshti University of Medical Sciences

af.sadeghi@sbmu.ac.ir+98 21 2290 8383

Outcome results

None listed

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