The comparison of premedication effect of intra-nasal dexmedetomidine and midazolam in anxiety level of children 2-8 years of age admitted for elective surgery

The comparison of premedication effect of intra-nasal dexmedetomidine and intra-nasal midazolam in sedation, anxiety level and ease of separation from parents in children 2-8 years of age admitted for elective surgery in academic hospitals of Rasht in 2013

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2012121611766N1

Enrollment

100

Registered

2013-02-17

Start date

2013-03-21

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

Children anexitey before general anesthesia. social anxiety disorder of childhood

Interventions

Intervention 1: Dexmedetomidine intranasal 1µg/kg with normal saline. Intervention 2: Midazolam intranasal 0.2 mg/kg with normal saline.

Prevention

Dexmedetomidine intranasal 1µg/kg with normal saline

Midazolam intranasal 0.2 mg/kg with normal saline

Eligibility

Sex/Gender

All

Age

2 Years to 8 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: children 2-8 years of age; ASA class I,II and candidate for elective surgery. Exclusion criteria:rejection by the patient's parents; rejection drugs by children; children have allergies to any medications,history of drugs affecting the central nervous system; disease involving the central nervous system; emergent surgery and duration of surgery under 1 hour or up to 2.5 hours.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sedation of children before surgery. Timepoint: During transfer to the operating room. Method of measurement: Ramsay 6 point scale.;Facilitate the separation of children from parents. Timepoint: During transfer to the operating room. Method of measurement: Feld 3 point scale.;Reduction of anxiety in children before surgery. Timepoint: During transfer to the operating room. Method of measurement: 4 point standard scale.	—

Measure

Time frame

Sedation of children before surgery. Timepoint: During transfer to the operating room. Method of measurement: Ramsay 6 point scale.;Facilitate the separation of children from parents. Timepoint: During transfer to the operating room. Method of measurement: Feld 3 point scale.;Reduction of anxiety in children before surgery. Timepoint: During transfer to the operating room. Method of measurement: 4 point standard scale.

—

Secondary

Measure	Time frame
Recovery duration. Timepoint: Enter to recovery and exit. Method of measurement: Timer.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Neda Ebrahimpour

Urology Research Center

urc1384@yahoo.com+98 13 1552 5259

Outcome results

None listed

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