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Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery

11 mai 2026 mis à jour par: Siyament cangir, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

84

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Turquie (Türkiye)
    • Outside of the US
      • Diyarbakır, Outside of the US, Turquie (Türkiye), 21070
        • Recrutement
        • Siyament Cangir
        • Contact:
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Midazolam Group
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.
Médicament: 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.
Autres noms:
  • Dormicum
Expérimental: Dexmedetomidine Group
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.
Médicament: 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.
Autres noms:
  • Précédent

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of patients achieving adequate sedation at anesthesia induction
Délai: 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
Approximately 30 minutes after premedication, at anesthesia induction

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Parent-child separation anxiety score
Délai: 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
At parent-child separation before anesthesia induction
Mask acceptance at induction
Délai: 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.
At the time of mask application during anesthesia induction
Postoperative emergence agitation
Délai: 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.
At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
Need for rescue sedation
Délai: From premedication until anesthesia induction
Requirement for rescue sedation during the preoperative period will be recorded as yes/no.
From premedication until anesthesia induction
PACU recovery time
Délai: 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.
During PACU stay until discharge criteria are met
Postoperative pain score
Délai: 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.
At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
Extubation time
Délai: Intraoperative to immediate postoperative period
Extubation time will be defined as the interval from discontinuation of volatile anesthetic to removal of the endotracheal tube.
Intraoperative to immediate postoperative period
Mean Arterial Pressure (MAP)
Délai: 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
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)
Délai: 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)
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)
Délai: 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 (%)
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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Les enquêteurs

  • Directeur d'études: Fatma Acil, M.D., Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

5 mai 2026

Achèvement primaire (Estimé)

1 août 2026

Achèvement de l'étude (Estimé)

26 septembre 2026

Dates d'inscription aux études

Première soumission

13 avril 2026

Première soumission répondant aux critères de contrôle qualité

27 avril 2026

Première publication (Réel)

4 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 27/01/2026-35

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.

Délai de partage IPD

Starting 6 months and ending 36 months following article publication.

Critères d'accès au partage IPD

Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to acilfatma@gmail.com

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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