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Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery

RecruitingNAAges 2 Years - 10 YearsAllSaglik Bilimleri Universitesi Gazi Yasargil Train…
NCT07565116 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 th

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Dexmedetomidine
  • Midazolam
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Where

1 site
Siyament Cangir
Diyarbakır, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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