Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery

Official title

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

Overview

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.

Detailed description

This prospective, randomized, double-blind, controlled clinical trial aims to compare intranasal dexmedetomidine and oral midazolam as premedication in pediatric patients undergoing elective inguinal and urological surgery under general anesthesia.

Premedication is essential in pediatric anesthesia to reduce preoperative anxiety, facilitate parent-child separation, and improve cooperation during anesthesia induction. Oral midazolam is widely used but has limitations such as variable bioavailability and potential adverse behavioral effects. Dexmedetomidine, a selective α2-adrenoreceptor agonist, has emerged as an alternative due to its sedative, anxiolytic, and minimal respiratory depressant effects.

Eligible pediatric patients will be prospectively enrolled and randomly assigned to receive either intranasal dexmedetomidine or oral midazolam. A double-blind design will be maintained by administering both oral and intranasal preparations in each group. Premedication will be administered prior to anesthesia induction, and perioperative clinical parameters will be recorded.

This study is expected to provide clinically relevant evidence regarding the effectiveness and safety of intranasal dexmedetomidine compared to oral midazolam, potentially contributing to improved premedication strategies in pediatric anesthesia.

Interventions

• Drug Dexmedetomidine
  Intranasal dexmedetomidine administered at a dose of 2 mcg/kg (maximum 200 mcg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.
• Drug Midazolam
  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.

Primary outcome measures

• Proportion of patients achieving adequate sedation at anesthesia induction [Time frame: Approximately 30 minutes after premedication, at anesthesia induction]

Secondary outcome measures (10)

• Parent-child separation anxiety score [Time frame: At parent-child separation before anesthesia induction]
• Mask acceptance at induction [Time frame: At the time of mask application during anesthesia induction]
• Postoperative emergence agitation [Time frame: At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9]
• Need for rescue sedation [Time frame: From premedication until anesthesia induction]
• PACU recovery time [Time frame: During PACU stay until discharge criteria are met]
• Postoperative pain score [Time frame: At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9]
• Extubation time [Time frame: Intraoperative to immediate postoperative period]
• Mean Arterial Pressure (MAP) [Time frame: At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).]
• Heart Rate (HR) [Time frame: At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).]
• Oxygen Saturation (SpO2) [Time frame: At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Siyament Cangir — Diyarbakır

Identifiers

NCT: NCT07565116 · 27/01/2026-35

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗