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Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery

11 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

84

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Geneesmiddel: 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.
Andere namen:
  • Slaapzaal
Experimenteel: 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.
Geneesmiddel: 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.
Andere namen:
  • Precedex

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of patients achieving adequate sedation at anesthesia induction
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Parent-child separation anxiety score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Onderzoekers

  • Studie directeur: Fatma Acil, M.D., Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 mei 2026

Primaire voltooiing (Geschat)

1 augustus 2026

Studie voltooiing (Geschat)

26 september 2026

Studieregistratiedata

Eerst ingediend

13 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 april 2026

Eerst geplaatst (Werkelijk)

4 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

11 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 27/01/2026-35

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

Starting 6 months and ending 36 months following article publication.

IPD-toegangscriteria voor delen

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

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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