Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Pediatric Anesthesia, Preoperative Anxiety, Emergence Agitation

In brief

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.

Key facts

Study ID

NCT07565116

Run by

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

People needed

84

Starts

2026-05-05

Expected to finish

2026-09-26

Last updated by the study team

2026-05-14

Who can join

Age: 2 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Siyament Cangir — Diyarbakır, Outside of the US, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.