RecruitingNot ApplicableNCT07565116

Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery

Comparison of Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Inguinal and Urological Surgery: A Prospective, Randomized, Double-Blind, Controlled Trial


Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Enrollment

84 participants

Start Date

May 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to compare the effects of intranasal dexmedetomidine and oral midazolam as premedication in pediatric patients undergoing elective inguinal and urological surgery under general anesthesia. Premedication plays a critical role in reducing preoperative anxiety, facilitating parent-child separation, and improving cooperation during anesthesia induction in pediatric patients. While oral midazolam is widely used, it has several limitations, including variable bioavailability and the risk of paradoxical reactions. Intranasal dexmedetomidine has emerged as a promising alternative due to its sedative, anxiolytic, and minimal respiratory depressant effects. In this prospective, randomized, double-blind, controlled study, patients aged 2-10 years will be assigned to receive either intranasal dexmedetomidine or oral midazolam prior to anesthesia induction. The primary outcome is the proportion of patients achieving adequate sedation at induction, defined as a Ramsay Sedation Score (RSS) ≥2. Secondary outcomes include perioperative hemodynamic stability, parent-child separation anxiety, mask acceptance during induction, postoperative emergence agitation, recovery time, and the need for rescue sedation.


Eligibility

Min Age: 2 YearsMax Age: 10 Years

Inclusion Criteria5

  • Pediatric patients aged 2-10 years
  • ASA physical status I-II
  • Scheduled for elective inguinal or urological surgery under general anesthesia
  • Both male and female patients
  • Written informed consent obtained from parents or legal guardians

Exclusion Criteria9

  • Known allergy or hypersensitivity to dexmedetomidine or midazolam
  • Presence of significant systemic disease or organ dysfunction
  • Cardiac arrhythmia or congenital heart disease
  • Neurological or behavioral disorders, including developmental delay
  • Chronic use of analgesics or other medications that may affect study outcomes
  • Anticipated difficult airway
  • Nasal pathology that may interfere with intranasal drug administration
  • Emergency surgery
  • Inability to obtain written informed consent from parents or legal guardians

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Interventions

DRUGDexmedetomidine

Intranasal dexmedetomidine administered at a dose of 1 mcg/kg (maximum 200 mcg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.

DRUGMidazolam

Oral midazolam administered at a dose of 0.5 mg/kg (maximum 15 mg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.


Locations(1)

Siyament Cangir

Diyarbakır, Outside of the US, Turkey (Türkiye)

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NCT07565116


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