The comparison of premedication effect of intranasal Ketamin and Midazolam in sedation of children and ease of separation from parents

The comparison of premedication effect of intranasal Ketamin and Midazolam in sedation and ease of separation from parents in children 2-6 years old admitted for elective urological surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016082411766N4

Enrollment

Registered

2016-09-21

Start date

2016-10-11

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

social anxiety disorder of childhood. Social anxiety disorder of childhood

Interventions

Intervention 1: Intervention 1: Intaranasal Midazolam 0.5mg/kg are administered.Ampule Midazolam with 5mg/cc Midazolam produced by Caspian company, Iran. Intervention 2: Intervention 2: Intranasal Ket

Prevention

Intervention 1: Intaranasal Midazolam 0.5mg/kg are administered.Ampule Midazolam with 5mg/cc Midazolam produced by Caspian company, Iran.

Intervention 2: Intranasal Ketamin 5mg/kg are administered.Vial ketamin with 50mg/cc Ketamin hydrocchloride produced by TRITTAU company, Germany

Eligibility

Sex/Gender

All

Age

2 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Children 2 to 6 years old with the weight of 10-20 kg;No history of allergy to any of the medications;No history of central nervous system drugs; Lack of disease involving the central nervous system, or psychological disorders Exclusion criteria:Emergency surgery;children or their parents refuse to take the medicine; estimate that duration of surgery is less than 1 hour or more than 3 hours.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sedation of children. Timepoint: During transfer to the operating room. Method of measurement: based on 5-point scale.;Facilitate the separation of children from parents. Timepoint: During transfer to the operating room. Method of measurement: based on 4-point scale.;Recovery time. Timepoint: Since time to enter recovery unit until exit from recovery unit. Method of measurement: Time(in minutes).	—

Secondary

Measure	Time frame
Post operation side effects(nausea,vomiting, apnea,hallucination). Timepoint: In recovery unit. Method of measurement: Yes/No.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Khoshrang

Guilan University of Medical Sciences

khoshrang@gums.ac.ir, hkhoshrang@yahoo.com+98 13 3335 9974

Outcome results

None listed

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