Use Of Midazolam In Premedication Of Pediatric Patients

NCT ID: NCT07021755

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-01
• Study Completion Date: 2009-12-01

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.

Detailed Description

Patients meeting with anesthesiologists before surgery for assessment and administration of premedication is important in terms of reducing morbidity and mortality linked to surgery and anesthesia. A study reported that 75% of children experience anxiety before surgery. This anxiety and worry observed in the pediatric patient group may cause tachycardia, hypertension and tachypnea due to increased catecholamine levels in the body and may cause aggressive reactions that are difficult to control. Additionally, it may make control of postoperative pain more difficult .

Several drugs are used before anesthesia to resolve surgical anxiety in pediatric patients and facilitate problem-free transfer to the operating room.

Midazolam is a benzodiazepine group drug, commonly used for preoperative medication for a long time. Reasons for it being chosen for premedication are that it ensure sedation and anxiolysis, has rapid onset of effect, and is more amnesic than diazepam . Though there are many routes to administer the drug, IM and IV routes are painful and frightening for patients. The premedication administration route must be acceptable for the child and not be traumatic. As a result, generally oral and intranasal routes are chosen for sedation of pediatric patients.

The aim of this study was to compare the effects of intranasal and oral midazolam, administered for premedication to preschool children, on hemodynamic parameters, sedation level and separation from parents, and in terms of complications.

The study was planned as prospective, randomized and single-blind research. After receiving permission from the ethics committee of our hospital (Haseki Clinical Research Ethics Committee No: 28.05.2009/10), the study included a total of 60 children aged 2-6 years in ASA ( Physical Status Classification System) I-II group, with elective surgery planned under general anesthetic. . Patients were allocated to two equal groups with the closed envelope method (Group O, n=30, 0.5 mg/kg oral midazolam; Group N, n=30, 0.25 mg/kg intranasal midazolam). Midazolam was administered 20 minutes before the operation. Vital signs and sedation score levels were recorded every 5 minutes. At the end of the 20th minute, the separation from parents score was assessed and recorded. Assessments were completed by an anesthesiologist who did not know the method of administration for premedication.

Conditions

Separation, Family; Separation Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

intranasal midazolam

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.

Group Type: EXPERIMENTAL

midazolam

Intervention Type: OTHER

oral midazolam

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.

Group Type: EXPERIMENTAL

midazolam

Intervention Type: OTHER

Interventions

midazolam

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ecder Ozenc

Role: STUDY_DIRECTOR

ozencecder@hotmail.com

Locations

Haseki training and research hospital

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SBU-ANESTHESİA-DMY-01

Identifier Type: -

Identifier Source: org_study_id