Use Of Midazolam In Premedication Of Pediatric Patients

NCT07021755 | Completed

• 1 other identifier: SBU-ANESTHESİA-DMY-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

: The aim of the study is to compare the effect of intranasal and oral midazolam administered for premedication to children of preschool age on hemodynamic parameters, sedation and separation from parents.

Conditions

Separation, Family; Separation Anxiety

Keywords

midazolam; premedication; children

Outcome Measures

Primary Outcomes (1)

• sedation

  The level of sedation was monitored every 5 minutes with the Ramsey sedation scale. Sedation scores of 1 and 2 were inadequate, while sedation scores of 3 and 4 were accepted as satisfactory

  five minute

Secondary Outcomes (1)

• separation from parents

  twenty minutes

Study Arms (2)

intranasal midazolam

EXPERIMENTAL

Twenty minutes before anesthesia induction, the first group were given 0.25 mg/kg intranasal midazolam and named Group N (n=30). Intranasal midazolam was administered by the parent with a 2 ml injector with the needle removed, with half the dose given into one nostril and the other half into the other nostril, while the patient was lying supine.

Other: midazolam

oral midazolam

EXPERIMENTAL

The second group were given 0.5 mg/kg oral midazolam and called Group O (n=30). Patients given oral midazolam drank the calculated midazolam dose mixed with 5 ml pulp-free fruit juice.

Other: midazolam

Interventions

midazolam OTHER

intranasal midazolam; oral midazolam

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA I-II group
• with elective surgery planned under general anesthetic.

You may not qualify if:

• Patients allergic to midazolam
• rhinorrhea
• respiratory system dysfunction like nasal polyp
• neurological or psychiatric disorder

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Haseki training and research hospital

Istanbul, Fatih, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety, Separation

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ecder Ozenc

  ozencecder@hotmail.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2024
• First Posted: June 15, 2025
• Study Start: June 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)