Pediatric AnesthesiaNCT07565116
Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery
A study testing Dexmedetomidine and Midazolam in people with Pediatric Anesthesia and Preoperative Anxiety, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Pediatric Anesthesia, Preoperative Anxiety, Emergence Agitation
- What is being tested?
- Dexmedetomidine and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2026to 26 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Nasal pathology that may interfere with intranasal drug administration
- Emergency surgery
- Inability to obtain written informed consent from parents or legal guardians
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Siyament Cangir
Diyarbakır, Outside of the US, 21070
Siyament Cangir, M.D., +905534411047, siyamentcangir@gmail.com
Fatma Acil, M.D., +905337225225, acilfatma@gmail.com
About this study
Official 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
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Dexmedetomidine, Midazolam
- Keywords
- Pediatric Anesthesia, Preoperative Anxiety, Emergence Agitation
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
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.
MidazolamDrug
Also called Dormicum
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.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Experimental | 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. Receives: 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. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately 30 minutes after premedication, at anesthesia induction
Secondary outcomes (10)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During PACU stay until discharge criteria are met
Postoperative pain score
Postoperative pain will be assessed using the FLACC scale.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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 (%)
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start5 May 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion26 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siyament cangir, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Fatma Acil, M.D., Study director, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565116
- Sponsor's protocol ID
- 27/01/2026-35
- Status last verified
- May 2026
- First submitted
- 13 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07565116
- Acronym / sponsor ID
- 27/01/2026-35
- Keywords
- Pediatric Anesthesia, Preoperative Anxiety, Emergence Agitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 26 Sep 2026 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: DexmedetomidineParticipants 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. |
| Midazolam Group | Active comparator | Drug: MidazolamParticipants 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. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: PrecedexIntranasal dexmedetomidine administered at a dose of 2 mcg/kg (maximum 200 mcg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients. | Drug | Dexmedetomidine Group |
| MidazolamAlso: DormicumOral 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. | Drug | Midazolam Group |
Primary outcome
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
10 secondary outcomes
Parent-child separation anxiety score
Time frame: At parent-child separation before anesthesia induction
Mask acceptance at induction
Time frame: At the time of mask application during anesthesia induction
Postoperative emergence agitation
Time frame: At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
Need for rescue sedation
Time frame: From premedication until anesthesia induction
PACU recovery time
Time frame: During PACU stay until discharge criteria are met
Postoperative pain score
Time frame: At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
Extubation time
Time frame: Intraoperative to immediate postoperative period
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatma Acil, M.D. study director
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Midazolam in people with Pediatric Anesthesia and Preoperative Anxiety, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siyament Cangir, M.D. (+905534411047, siyamentcangir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving adequate sedation at anesthesia induction (time frame: Approximately 30 minutes after premedication, at anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.