Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery

NCT07565116 | Recruiting

• 1 other identifier: 27/01/2026-35
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Anesthesia; Preoperative Anxiety; Emergence Agitation

Keywords

Pediatric Anesthesia; Preoperative Anxiety; Emergence Agitation

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving adequate sedation at anesthesia induction

  Adequate sedation is defined as a Ramsay Sedation Score (RSS) ≥2 assessed immediately before mask application at the time of anesthesia induction

  Approximately 30 minutes after premedication, at anesthesia induction

Secondary Outcomes (10)

• Parent-child separation anxiety score

  At parent-child separation before anesthesia induction

• Mask acceptance at induction

  At the time of mask application during anesthesia induction

• Postoperative emergence agitation

  At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9

• Need for rescue sedation

  From premedication until anesthesia induction

• PACU recovery time

  During PACU stay until discharge criteria are met

Study Arms (2)

Dexmedetomidine Group

EXPERIMENTAL

Participants in this group will receive intranasal dexmedetomidine at a dose of 1 mcg/kg (maximum 200 mcg) as premedication prior to anesthesia induction, along with oral placebo to maintain blinding.

Drug: Dexmedetomidine

Midazolam Group

ACTIVE COMPARATOR

Participants in this group will receive oral midazolam at a dose of 0.5 mg/kg (maximum 15 mg) as premedication 30 minutes prior to anesthesia induction, along with intranasal placebo to maintain blinding. This approach ensures consistent administration routes across study groups.

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

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.

Dexmedetomidine Group

Midazolam DRUG

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.

Midazolam Group

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Siyament Cangir

Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Fatma Acil, M.D.

  Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Siyament Cangir, M.D.

CONTACT

+905534411047; siyamentcangir@gmail.com

Fatma K Acil, M.D.

CONTACT

+905337225225; acilfatma@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study in which both participants and outcome assessors are blinded to treatment allocation. Study drugs are prepared by an independent investigator. To ensure blinding, both oral and intranasal administrations are given to all participants, with one active drug and one placebo in each group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups to receive either intranasal dexmedetomidine or oral midazolam as premedication. Both groups will receive both intranasal and oral administrations to maintain blinding, with one active drug and one placebo in each group.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 4, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 26, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

TU (1)