An interventional study of Dexmedetomidine and Midazolam in Pediatric Anesthesia, Preoperative Anxiety and Emergence Agitation, sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.
This study's planned enrollment of 84 is below the median of 120 across 475 interventional studies indexed under Emergence Delirium.
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Exclusion Criteria:
Participants in this group will receive intranasal dexmedetomidine at a dose of 2 mcg/kg (maximum 200 mcg) as premedication prior to anesthesia induction, along with oral placebo to maintain blinding.
Drug: Dexmedetomidine
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
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.
Also known as: Precedex
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.
Also known as: Dormicum
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
Time frame: Approximately 30 minutes after premedication, at anesthesia induction
Parent-child separation anxiety score
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
Time frame: At parent-child separation before anesthesia induction
Mask acceptance at 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.
Time frame: At the time of mask application during anesthesia induction
Postoperative emergence agitation
Emergence agitation will be assessed using the Watcha Behavior Scale (WDS). Agitation will be defined as WDS \>2.
Time frame: At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
Need for rescue sedation
Requirement for rescue sedation during the preoperative period will be recorded as yes/no.
Time frame: From premedication until anesthesia induction
PACU recovery time
Recovery time will be defined as the time from admission to the post-anesthesia care unit until achievement of Aldrete score ≥9.
Time frame: During PACU stay until discharge criteria are met
Postoperative pain score
Postoperative pain will be assessed using the FLACC scale.
Time frame: At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
Extubation time
Extubation time will be defined as the interval from discontinuation of volatile anesthetic to removal of the endotracheal tube.
Time frame: Intraoperative to immediate postoperative period
Mean Arterial Pressure (MAP)
Mean arterial pressure (MAP) will be monitored to evaluate hemodynamic stability during the perioperative period. Unit of Measure: mmHg
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)
Heart rate (HR) will be recorded to monitor cardiac stability and response to anesthesia. Unit of Measure: Beats per minute (bpm)
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)
SpO2 levels will be monitored via pulse oximetry to evaluate respiratory and hemodynamic status. Unit of Measure: Percentage (%)
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).
Plan to share: Yes — De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.
Supporting information: Study protocol, Icf
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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital