AdenotonsillectomyTiming-MidazolNCT07622641
Timing Of Midazolam İn Children Undergoing Adenotonsillectomy: Effects On Stress, Cortisol, And Recovery
A study testing Midazolam (Oral) and Midazolam (Intravenous) in people with Adenotonsillectomy and Preoperative Anxiety, run by Erzurum City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study is a prospective, randomized, controlled clinical trial designed to evaluate the optimal timing of midazolam administration in children undergoing adenotonsillectomy. The study will be conducted at the Departments of Otorhinolaryngology and Anesthesiology of Erzurum City Hospital. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Adenotonsillectomy, Preoperative Anxiety, Surgical Stress Response
- What is being tested?
- Midazolam (Oral) and Midazolam (Intravenous)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 1 Sep 2027
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3-10 years,
- Scheduled for elective adenoidectomy, tonsillectomy, or adenotonsillectomy,
- American Society of Anesthesiologists (ASA) physical status I-II,
- Written informed consent obtained from parents or legal guardians
Who cannot join
- Children younger than 3 years or older than 10 years,
- American Society of Anesthesiologists (ASA) physical status greater than II,
- Known allergy to apple or apple-derived products,
- Known allergy or hypersensitivity to benzodiazepines,
- Presence of developmental delay,
- History of neuropsychiatric disorders,
Show all 9Show fewer
- Current or recent use of corticosteroids,
- Expected or actual surgical duration longer than 90 minutes,
- Refusal of participation by 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.
Ahmet Ergün, MD contact
Turkey (Türkiye)1 site
Erzurum City Hospital
Erzurum, Yakutiye, 25240
Ahmet Ergün, MD
About this study
Official title: Optimization of Midazolam Administration Timing in Pediatric Adenotonsillectomy: Effects on Cortisol Response, Behavioral Stress, and Recovery Quality
This study is a prospective, randomized, controlled clinical trial designed to evaluate the optimal timing of midazolam administration in children undergoing adenotonsillectomy. The study will be conducted at the Departments of Otorhinolaryngology and Anesthesiology of Erzurum City Hospital.
Midazolam is commonly used in pediatric patients to reduce anxiety and improve perioperative comfort. However, the optimal timing of its administration (before surgery or during anesthesia induction) remains unclear. This study aims to compare the effects of preoperative oral midazolam and intraoperative intravenous midazolam on stress response, behavioral outcomes, and recovery quality.
Read more
Participants will be randomly assigned to one of two groups. In Group A, children will receive oral midazolam (0.5 mg/kg) 30 minutes before surgery. In Group B, children will receive intravenous midazolam (0.05-0.1 mg/kg) during anesthesia induction.
The primary outcome of the study is the change in serum cortisol levels, which reflects the physiological stress response. Blood samples will be collected twice: once 10 minutes after anesthesia induction and once 15 minutes after surgery in the post-anesthesia care unit.
In addition to cortisol levels, the study will assess preoperative anxiety using an observational anxiety scale, postoperative pain using a behavioral pain scoring system, and parental satisfaction using a standardized questionnaire. These measures aim to provide a comprehensive evaluation of the child's perioperative experience.
The findings of this study may help determine the most effective timing of midazolam administration to reduce stress, improve recovery, and enhance overall patient and family satisfaction in pediatric surgical care.
Read the detailed description
This study is a prospective, randomized, controlled clinical trial designed to evaluate the effects of the timing of midazolam administration on physiological stress response, behavioral anxiety, postoperative pain, recovery quality, and parental satisfaction in pediatric patients undergoing elective adenotonsillectomy.
The primary objective is to compare the effect of midazolam administration timing on physiological stress response, assessed by serum cortisol levels. Secondary objectives include evaluating preoperative anxiety levels, postoperative pain scores, recovery quality, and parental satisfaction between groups receiving midazolam at different time points.
The study will include children aged 3-10 years, classified as ASA physical status I-II, scheduled for elective adenoidectomy, tonsillectomy, or adenotonsillectomy.
Eligible patients will be identified during preoperative anesthesia evaluation. Parents or legal guardians will be informed about the study, and written informed consent will be obtained prior to enrollment.
Participants will be randomly assigned to one of two groups using a computer-generated randomization sequence with sealed envelope allocation:
Group A (Preoperative Midazolam Group): Patients will receive oral midazolam (0.5 mg/kg) 30 minutes before surgery, administered with a small volume of apple juice under clinical supervision.
Group B (Intraoperative Midazolam Group): Patients will receive intravenous midazolam (0.05-0.1 mg/kg) during anesthesia induction.
Anesthesia Protocol
To ensure comparability between groups, all patients will undergo a standardized anesthesia protocol. Vascular access will be established after inhalational induction using sevoflurane in oxygen, minimizing stress associated with intravenous cannulation.
Lidocaine (0.5-1 mg/kg) will be administered prior to propofol injection to reduce injection pain Propofol (2-3 mg/kg) will be used for induction Rocuronium (0.6 mg/kg) will be administered for neuromuscular blockade Fentanyl (1-2 µg/kg) will be used for analgesia
Anesthesia maintenance will be achieved with sevoflurane (2-3%) in a mixture of oxygen and air, targeting an age-adjusted MAC ≥1.3. Mechanical ventilation will be standardized with volume-controlled settings appropriate for age.
Intraoperative fluid management will be based on body weight using standard pediatric maintenance formulas and isotonic saline solution.
Neuromuscular blockade will be reversed with sugammadex (2 mg/kg) Extubation will be performed based on clinical recovery criteria, including adequate spontaneous respiration and responsiveness
All patients will receive intravenous paracetamol (10-15 mg/kg) for postoperative analgesia and ondansetron (0.1 mg/kg) for prophylaxis of nausea and vomiting.
Serum cortisol levels will be measured at two time points:
Intraoperative period (10 minutes after anesthesia induction) Early postoperative period (15 minutes after admission to the post-anesthesia care unit)
Cortisol levels will be analyzed using an electrochemiluminescence immunoassay method.
Preoperative anxiety will be assessed using a modified observational anxiety scale. Postoperative pain will be evaluated using a validated behavioral pain scoring system, and recovery status will be assessed using standard recovery criteria.
Parental satisfaction will be evaluated within the first 30 minutes after surgery using a structured questionnaire assessing overall perioperative experience.
All perioperative data will be recorded by the anesthesia team and post-anesthesia care unit staff. Collected data will be analyzed statistically to compare outcomes between the two groups.
- Being tested
- Midazolam (Oral), Midazolam (Intravenous)
- Keywords
- Midazolam, Pediatric Anesthesia, Adenotonsillectomy, Premedication Timing, Preoperative Anxiety, Cortisol Response, Postoperative Pain, Recovery Quality
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam (Oral)Drug
Oral midazolam will be administered at a dose of 0.5 mg/kg, 30 minutes before surgery. The medication will be mixed with a small volume of apple juice to facilitate administration.
Midazolam (Intravenous)Drug
Intravenous midazolam will be administered at a dose of 0.05-0.1 mg/kg during anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Oral Midazolam | Experimental | Participants in this group will receive oral midazolam at a dose of 0.5 mg/kg, administered 30 minutes before surgery. The medication will be mixed with a small volume of apple juice to facilitate administration and improve tolerance. Receives: Drug: Midazolam (Oral) |
| Intraoperative Intravenous Midazolam | Experimental | Participants in this group will receive intravenous midazolam at a dose of 0.05-0.1 mg/kg during anesthesia induction. Receives: Drug: Midazolam (Intravenous) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Cortisol Levels
Serum cortisol levels will be measured to assess physiological stress response.
Measured: At 10 minutes after anesthesia induction and at 15 minutes postoperatively in the post-anesthesia care unit (PACU)
Secondary outcomes (4)
Preoperative Anxiety Level (mYPAS Score)
Preoperative anxiety will be assessed using the modified Yale Preoperative Anxiety Scale (mYPAS), an observational tool evaluating behavioral anxiety in children across multiple domains. Scores will be normalized to a 0-100 scale, with higher scores indicating greater anxiety.
Measured: During the preoperative period before anesthesia induction
Postoperative Pain Score (FLACC Score)
Postoperative pain will be evaluated using the FLACC (Face, Legs, Activity, Cry, Consolability) scale, a validated behavioral pain assessment tool for pediatric patients. Each category is scored from 0 to 2, with a total score ranging from 0 to 10, where higher scores indicate more severe pain.
Measured: At 15 minutes postoperatively in the post-anesthesia care unit (PACU)
Recovery Status (Modified Aldrete Score)
Recovery status will be assessed using the Modified Aldrete Score, which evaluates activity, respiration, circulation, consciousness, and oxygen saturation. Higher scores indicate better recovery and readiness for discharge from the PACU.
Measured: Within the first 30 minutes postoperatively in the PACU
Parental Satisfaction (PAPS Survey)
Parental satisfaction will be evaluated using the Pediatric Anesthesia Parent Satisfaction (PAPS) survey, a structured questionnaire assessing satisfaction with perioperative care, including communication, pain management, and overall experience. Scores range from 5 to 25, with higher scores indicating greater satisfaction.
Measured: Within 30 minutes after the child becomes clinically stable in the postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenotonsillectomyStudies 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 based on the timing of midazolam administration (preoperative oral vs intraoperative intravenous). Randomization will be performed using a computer-generated sequence with sealed envelope allocation. Each participant will receive only one intervention, and outcomes will be compared between groups.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzurum City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Sercan Orbak, Erzurum City Hospital
- Investigators
- Mehmet Sercan Orbak, MD, Principal investigator, Erzurum City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622641
- Sponsor's protocol ID
- ECH-AR-MSO-02
- Acronym
- Timing-Midazol
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly available due to institutional and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Midazolam Administration Timing in Pediatric Adenotonsillectomy: Effects on Cortisol Response, Behavioral Stress, and Recovery Quality
- ClinicalTrials.gov ID
- NCT07622641
- Acronym / sponsor ID
- Timing-Midazol / ECH-AR-MSO-02
- Keywords
- Midazolam, Pediatric Anesthesia, Adenotonsillectomy, Premedication Timing, Preoperative Anxiety, Cortisol Response, Postoperative Pain, Recovery Quality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erzurum City HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 3 Jun 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 is a prospective, randomized, controlled clinical trial designed to evaluate the optimal timing of midazolam administration in children undergoing adenotonsillectomy. The study will be conducted at the Departments of Otorhinolaryngology and Anesthesiology of Erzurum City Hospital.
Midazolam is commonly used in pediatric patients to reduce anxiety and improve perioperative comfort. However, the optimal timing of its administration (before surgery or during anesthesia induction) remains unclear. This study aims to compare the effects of preoperative oral midazolam and intraoperative intravenous midazolam on stress response, behavioral outcomes, and recovery quality.
Participants will be randomly assigned to one of two groups. In Group A, children will receive oral midazolam (0.5 mg/kg) 30 minutes before surgery. In Group B, children will receive intravenous midazolam (0.05-0.1 mg/kg) during anesthesia induction.
The primary outcome of the study is the change in serum cortisol levels, which reflects the physiological stress response. Blood samples will be collected twice: once 10 minutes after anesthesia induction and once 15 minutes after surgery in the post-anesthesia care unit.
In addition to cortisol levels, the study will assess preoperative anxiety using an observational anxiety scale, postoperative pain using a behavioral pain scoring system, and parental satisfaction using a standardized questionnaire. These measures aim to provide a comprehensive evaluation of the child's perioperative experience.
The findings of this study may help determine the most effective timing of midazolam administration to reduce stress, improve recovery, and enhance overall patient and family satisfaction in pediatric surgical care.
Detailed description
This study is a prospective, randomized, controlled clinical trial designed to evaluate the effects of the timing of midazolam administration on physiological stress response, behavioral anxiety, postoperative pain, recovery quality, and parental satisfaction in pediatric patients undergoing elective adenotonsillectomy.
The primary objective is to compare the effect of midazolam administration timing on physiological stress response, assessed by serum cortisol levels. Secondary objectives include evaluating preoperative anxiety levels, postoperative pain scores, recovery quality, and parental satisfaction between groups receiving midazolam at different time points.
The study will include children aged 3-10 years, classified as ASA physical status I-II, scheduled for elective adenoidectomy, tonsillectomy, or adenotonsillectomy.
Eligible patients will be identified during preoperative anesthesia evaluation. Parents or legal guardians will be informed about the study, and written informed consent will be obtained prior to enrollment.
Participants will be randomly assigned to one of two groups using a computer-generated randomization sequence with sealed envelope allocation:
Group A (Preoperative Midazolam Group): Patients will receive oral midazolam (0.5 mg/kg) 30 minutes before surgery, administered with a small volume of apple juice under clinical supervision.
Group B (Intraoperative Midazolam Group): Patients will receive intravenous midazolam (0.05-0.1 mg/kg) during anesthesia induction.
Anesthesia Protocol
To ensure comparability between groups, all patients will undergo a standardized anesthesia protocol. Vascular access will be established after inhalational induction using sevoflurane in oxygen, minimizing stress associated with intravenous cannulation.
Lidocaine (0.5-1 mg/kg) will be administered prior to propofol injection to reduce injection pain Propofol (2-3 mg/kg) will be used for induction Rocuronium (0.6 mg/kg) will be administered for neuromuscular blockade Fentanyl (1-2 µg/kg) will be used for analgesia
Anesthesia maintenance will be achieved with sevoflurane (2-3%) in a mixture of oxygen and air, targeting an age-adjusted MAC ≥1.3. Mechanical ventilation will be standardized with volume-controlled settings appropriate for age.
Intraoperative fluid management will be based on body weight using standard pediatric maintenance formulas and isotonic saline solution.
Neuromuscular blockade will be reversed with sugammadex (2 mg/kg) Extubation will be performed based on clinical recovery criteria, including adequate spontaneous respiration and responsiveness
All patients will receive intravenous paracetamol (10-15 mg/kg) for postoperative analgesia and ondansetron (0.1 mg/kg) for prophylaxis of nausea and vomiting.
Serum cortisol levels will be measured at two time points:
Intraoperative period (10 minutes after anesthesia induction) Early postoperative period (15 minutes after admission to the post-anesthesia care unit)
Cortisol levels will be analyzed using an electrochemiluminescence immunoassay method.
Preoperative anxiety will be assessed using a modified observational anxiety scale. Postoperative pain will be evaluated using a validated behavioral pain scoring system, and recovery status will be assessed using standard recovery criteria.
Parental satisfaction will be evaluated within the first 30 minutes after surgery using a structured questionnaire assessing overall perioperative experience.
All perioperative data will be recorded by the anesthesia team and post-anesthesia care unit staff. Collected data will be analyzed statistically to compare outcomes between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups based on the timing of midazolam administration (preoperative oral vs intraoperative intravenous). Randomization will be performed using a computer-generated sequence with sealed envelope allocation. Each participant will receive only one intervention, and outcomes will be compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Preoperative Oral Midazolam | Experimental | Drug: Midazolam (Oral)Participants in this group will receive oral midazolam at a dose of 0.5 mg/kg, administered 30 minutes before surgery. The medication will be mixed with a small volume of apple juice to facilitate administration and improve tolerance. |
| Intraoperative Intravenous Midazolam | Experimental | Drug: Midazolam (Intravenous)Participants in this group will receive intravenous midazolam at a dose of 0.05-0.1 mg/kg during anesthesia induction. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 3-10 years,
- Scheduled for elective adenoidectomy, tonsillectomy, or adenotonsillectomy,
- American Society of Anesthesiologists (ASA) physical status I-II,
- Written informed consent obtained from parents or legal guardians
Key exclusion criteria (9 listed)
- Children younger than 3 years or older than 10 years,
- American Society of Anesthesiologists (ASA) physical status greater than II,
- Known allergy to apple or apple-derived products,
- Known allergy or hypersensitivity to benzodiazepines,
- Presence of developmental delay,
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 |
|---|---|---|
| Midazolam (Oral)Oral midazolam will be administered at a dose of 0.5 mg/kg, 30 minutes before surgery. The medication will be mixed with a small volume of apple juice to facilitate administration. | Drug | Preoperative Oral Midazolam |
| Midazolam (Intravenous)Intravenous midazolam will be administered at a dose of 0.05-0.1 mg/kg during anesthesia induction. | Drug | Intraoperative Intravenous Midazolam |
Primary outcome
Change in Serum Cortisol Levels
Time frame: At 10 minutes after anesthesia induction and at 15 minutes postoperatively in the post-anesthesia care unit (PACU)
Serum cortisol levels will be measured to assess physiological stress response.
4 secondary outcomes
Preoperative Anxiety Level (mYPAS Score)
Time frame: During the preoperative period before anesthesia induction
Postoperative Pain Score (FLACC Score)
Time frame: At 15 minutes postoperatively in the post-anesthesia care unit (PACU)
Recovery Status (Modified Aldrete Score)
Time frame: Within the first 30 minutes postoperatively in the PACU
Parental Satisfaction (PAPS Survey)
Time frame: Within 30 minutes after the child becomes clinically stable in the postoperative period
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 10 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly available due to institutional and ethical restrictions.
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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.
Ahmet Ergün, MD contact
Mehmet Sercan Orbak, MD principal investigator
Erzurum City 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 Midazolam (Oral) and Midazolam (Intravenous) in people with Adenotonsillectomy and Preoperative Anxiety, run by Erzurum City 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 4 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: opening soon, as of the sponsor's last update on 10 Jun 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 Mehmet Sercan Orbak, MD (+ 90 (506) 288 35 34, sercanorbak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Cortisol Levels (time frame: At 10 minutes after anesthesia induction and at 15 minutes postoperatively in the post-anesthesia care unit (PACU)). 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 10 Jun 2026.