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NCT Number: NCT07565116

Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery

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.

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Key information

Conditions

Pediatric Anesthesia Confusion Delirium Emergence Agitation Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Preoperative Anxiety Signs and Symptoms

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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.

Other names: Precedex

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.

Other names: Dormicum

Primary outcomes

  1. Proportion of patients achieving adequate sedation at anesthesia induction

    Time frame: Approximately 30 minutes after premedication, 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

Secondary outcomes

  1. Parent-child separation anxiety score

    Time frame: At parent-child separation before anesthesia induction

    Parent-child separation anxiety will be assessed using the Parental Separation Anxiety Scale (PSAS). The scale ranges from 1 to 4, where 1 indicates "calm/easy separation" and 4 indicates "crying/extreme difficulty in separation." Higher scores represent worse outcomes (higher levels of anxiety). A score of >2 is defined as significant separation anxiety.

    Unit of Measure: Units on a scale

  2. Mask acceptance at induction

    Time frame: At the time of mask application during anesthesia induction

    Mask acceptance will be assessed using the Mask Acceptance Scale (MAS ) at the time of mask application during anesthesia induction. Mask Acceptance will be defined as WDS 1-2.

  3. Postoperative emergence agitation

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

    Emergence agitation will be assessed using the Watcha Behavior Scale (WDS). Agitation will be defined as WDS >2.

  4. Need for rescue sedation

    Time frame: From premedication until anesthesia induction

    Requirement for rescue sedation during the preoperative period will be recorded as yes/no.

  5. PACU recovery time

    Time frame: During PACU stay until discharge criteria are met

    Recovery time will be defined as the time from admission to the post-anesthesia care unit until achievement of Aldrete score ≥9.

  6. Postoperative pain score

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

    Postoperative pain will be assessed using the FLACC scale.

  7. Extubation time

    Time frame: Intraoperative to immediate postoperative period

    Extubation time will be defined as the interval from discontinuation of volatile anesthetic to removal of the endotracheal tube.

  8. 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).

    Mean arterial pressure (MAP) will be monitored to evaluate hemodynamic stability during the perioperative period.

    Unit of Measure: mmHg

  9. 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).

    Heart rate (HR) will be recorded to monitor cardiac stability and response to anesthesia.

    Unit of Measure: Beats per minute (bpm)

  10. 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).

    SpO2 levels will be monitored via pulse oximetry to evaluate respiratory and hemodynamic status.

    Unit of Measure: Percentage (%)

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma K Acil, M.D.

CONTACT

[email protected]

+905337225225

Siyament Cangir, M.D.

CONTACT

[email protected]

+905534411047

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 4, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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