Pediatric AnesthesiaNCT07410078
Comparative Assessment of Oral Premedication Regimens in Pediatric Ambulatory Surgery
A study testing Oral Midazolam Premedication, Oral Midazolam plus Ibuprofen Premedication and Oral Midazolam plus Ketamine Premedication in people with Pediatric Anesthesia and Premedication, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, three-arm study aims to evaluate the effects of different oral premedication regimens on venipuncture tolerance in pediatric patients undergoing ambulatory surgery. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Pediatric Anesthesia, Premedication
- What is being tested?
- Oral Midazolam Premedication, Oral Midazolam plus Ibuprofen Premedication and Oral Midazolam plus Ketamine Premedication
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jul 2026to 1 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 4-12 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective ambulatory (day-case) surgery
- Eligible to receive oral premedication
- Cognitive ability sufficient to complete behavioral and pain scale assessments
- Written informed consent obtained from a parent or legal guardian
Who cannot join
- ASA physical status III or higher
- Moderate to severe intellectual disability
- Moderate to severe autism spectrum disorder
- Known allergy or contraindication to midazolam, ketamine, or ibuprofen
- History of sedative or opioid use within the previous 24 hours
- Complete loss of premedication due to vomiting
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
Ankara Etlik City Hospital
Ankara, 06000
Elif Şule Özdemir Sezgi, M.D., 00905059209638, elifsule-91@hotmail.com
Aslı Dönmez, Professor, 00905322256473, aslidonmez@hotmail.com
About this study
Official title: A Comparative Evaluation of Oral Premedication Regimens in Pediatric Patients Undergoing Ambulatory Surgery
This prospective, three-arm study aims to evaluate the effects of different oral premedication regimens on venipuncture tolerance in pediatric patients undergoing ambulatory surgery. Children aged 4-12 years scheduled for elective day-case procedures will receive oral midazolam alone, midazolam combined with ibuprofen, or midazolam combined with ketamine prior to anesthesia induction. The primary outcome is the proportion of children with well-tolerated venipuncture, assessed using standardized behavioral and pain scales. Secondary outcomes include anxiety levels, venipuncture success parameters, time to successful intravenous access, and parent and anesthesiologist satisfaction. In cases of inadequate premedication or failed venipuncture, a predefined rescue inhalational induction protocol will be applied to ensure patient safety. The study aims to identify clinically effective premedication strategies that may improve cooperation and reduce distress during intravenous cannulation in pediatric ambulatory anesthesia.
- Conditions
- Pediatric Anesthesia, Premedication
- Being tested
- Oral Midazolam Premedication, Oral Midazolam plus Ibuprofen Premedication, Oral Midazolam plus Ketamine Premedication
- Keywords
- Pediatric Anesthesia, Premedication, Ambulatory surgery, Venipuncture tolerance, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Midazolam PremedicationProcedure or surgery
Participants in this group will receive oral midazolam approximately 20 minutes before transfer to the operating room. The medication will be administered as a single dose prior to intravenous cannulation. Behavioral and pain-related assessments will be recorded during intravenous cannulation.
Oral Midazolam plus Ibuprofen PremedicationProcedure or surgery
Participants in this group will receive oral midazolam and oral ibuprofen approximately 20 minutes before transfer to the operating room. Both medications will be administered as a single dose prior to intravenous cannulation. Behavioral and pain-related assessments will be recorded during intravenous cannulation.
Oral Midazolam plus Ketamine PremedicationProcedure or surgery
Participants in this group will receive oral midazolam and oral ketamine approximately 20 minutes before transfer to the operating room. Both medications will be administered as a single dose prior to intravenous cannulation. Behavioral and pain-related assessments will be recorded during intravenous cannulation.
| Study group | Role | What they receive |
|---|---|---|
| Oral Midazolam Premedication | Active comparator | Participants in this arm will receive oral midazolam as premedication at a dose of 0.5 mg/kg (maximum 15 mg), administered approximately 20 minutes before transfer to the operating room. The medications will be administered once prior to anesthesia induction. Venipuncture tolerance, anxiety, and pain-related outcomes will be assessed during intravenous cannulation. Receives: Procedure: Oral Midazolam Premedication |
| Oral Midazolam plus Ibuprofen Premedication | Active comparator | Participants in this arm will receive a combination of oral midazolam at a dose of 0.5 mg/kg (maximum 15 mg) and oral ibuprofen at a dose of 10 mg/kg, administered approximately 20 minutes before transfer to the operating room. The medications will be administered once prior to anesthesia induction. Venipuncture tolerance, anxiety, and pain-related outcomes will be assessed during intravenous cannulation. Receives: Procedure: Oral Midazolam plus Ibuprofen Premedication |
| Oral Midazolam plus Ketamine Premedication | Active comparator | Participants in this arm will receive oral midazolam at a dose of 0.5 mg/kg (maximum 15 mg) combined with oral ketamine at a dose of 3 mg/kg, administered approximately 20 minutes before transfer to the operating room. The medications will be administered once prior to anesthesia induction. Venipuncture tolerance, anxiety, and pain-related outcomes will be assessed during intravenous cannulation. Receives: Procedure: Oral Midazolam plus Ketamine Premedication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Well-Tolerated Venipuncture
The proportion of children with well-tolerated venipuncture during intravenous cannulation, assessed using the Children's Fear Scale (CFS), a validated 5-point scale ranging from 0 to 4 (0 = no fear; 4 = extreme fear). Well-tolerated venipuncture is defined as a CFS score < 3 at the time of the venipuncture attempt.
Measured: During intravenous cannulation in the operating room
Secondary outcomes (2)
Anxiety Scores
The mYPAS is an observational behavioral scale consisting of five domains (activity, vocalization, emotional expressivity, state of arousal, and use of parents). Scores are calculated using the original weighted scoring algorithm and generate a standardized total score ranging from 23.3 to 100, with higher scores indicating greater anxiety.
Clinically significant anxiety is defined as mYPAS ≥ 30.
Measured: Assessed preoperatively before oral premedication and after premedication in the preoperative holding area.
Pain Scores During Venipuncture
Pain intensity assessed using the Wong-Baker Faces Pain Rating Scale, a validated 6-face scale scored from 0 to 10:
0 = no pain 10 = worst pain imaginable Higher scores indicate greater pain intensity.
Measured: During intravenous cannulation in the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start26 Jul 2026
- Primary completion19 Aug 2026 (estimated)
- Study completion1 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Sule Ozdemir, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410078
- Sponsor's protocol ID
- AEŞH-EK-2025-320
- Status last verified
- Jul 2026
- First submitted
- 7 Feb 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Oral Premedication Regimens in Pediatric Patients Undergoing Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT07410078
- Acronym / sponsor ID
- AEŞH-EK-2025-320
- Conditions
- Pediatric Anesthesia, Premedication
- Keywords
- Pediatric Anesthesia, Premedication, Ambulatory surgery, Venipuncture tolerance, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 26 Jul 2026 (actual)
- Primary completion
- 19 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 13 Feb 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 prospective, three-arm study aims to evaluate the effects of different oral premedication regimens on venipuncture tolerance in pediatric patients undergoing ambulatory surgery. Children aged 4-12 years scheduled for elective day-case procedures will receive oral midazolam alone, midazolam combined with ibuprofen, or midazolam combined with ketamine prior to anesthesia induction. The primary outcome is the proportion of children with well-tolerated venipuncture, assessed using standardized behavioral and pain scales. Secondary outcomes include anxiety levels, venipuncture success parameters, time to successful intravenous access, and parent and anesthesiologist satisfaction. In cases of inadequate premedication or failed venipuncture, a predefined rescue inhalational induction protocol will be applied to ensure patient safety. The study aims to identify clinically effective premedication strategies that may improve cooperation and reduce distress during intravenous cannulation in pediatric ambulatory anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Midazolam Premedication | Active comparator | Procedure: Oral Midazolam PremedicationParticipants in this arm will receive oral midazolam as premedication at a dose of 0.5 mg/kg (maximum 15 mg), administered approximately 20 minutes before transfer to the operating room. The medications will be administered once prior to anesthesia induction. Venipuncture tolerance, anxiety, and pain-related outcomes will be assessed during intravenous cannulation. |
| Oral Midazolam plus Ibuprofen Premedication | Active comparator | Procedure: Oral Midazolam plus Ibuprofen PremedicationParticipants in this arm will receive a combination of oral midazolam at a dose of 0.5 mg/kg (maximum 15 mg) and oral ibuprofen at a dose of 10 mg/kg, administered approximately 20 minutes before transfer to the operating room. The medications will be administered once prior to anesthesia induction. Venipuncture tolerance, anxiety, and pain-related outcomes will be assessed during intravenous cannulation. |
| Oral Midazolam plus Ketamine Premedication | Active comparator | Procedure: Oral Midazolam plus Ketamine PremedicationParticipants in this arm will receive oral midazolam at a dose of 0.5 mg/kg (maximum 15 mg) combined with oral ketamine at a dose of 3 mg/kg, administered approximately 20 minutes before transfer to the operating room. The medications will be administered once prior to anesthesia induction. Venipuncture tolerance, anxiety, and pain-related outcomes will be assessed during intravenous cannulation. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Pediatric patients aged 4-12 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective ambulatory (day-case) surgery
- Eligible to receive oral premedication
- Cognitive ability sufficient to complete behavioral and pain scale assessments
Key exclusion criteria (6 listed)
- ASA physical status III or higher
- Moderate to severe intellectual disability
- Moderate to severe autism spectrum disorder
- Known allergy or contraindication to midazolam, ketamine, or ibuprofen
- History of sedative or opioid use within the previous 24 hours
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 |
|---|---|---|
| Oral Midazolam PremedicationParticipants in this group will receive oral midazolam approximately 20 minutes before transfer to the operating room. The medication will be administered as a single dose prior to intravenous cannulation. Behavioral and pain-related assessments will be recorded during intravenous cannulation. | Procedure or surgery | Oral Midazolam Premedication |
| Oral Midazolam plus Ibuprofen PremedicationParticipants in this group will receive oral midazolam and oral ibuprofen approximately 20 minutes before transfer to the operating room. Both medications will be administered as a single dose prior to intravenous cannulation. Behavioral and pain-related assessments will be recorded during intravenous cannulation. | Procedure or surgery | Oral Midazolam plus Ibuprofen Premedication |
| Oral Midazolam plus Ketamine PremedicationParticipants in this group will receive oral midazolam and oral ketamine approximately 20 minutes before transfer to the operating room. Both medications will be administered as a single dose prior to intravenous cannulation. Behavioral and pain-related assessments will be recorded during intravenous cannulation. | Procedure or surgery | Oral Midazolam plus Ketamine Premedication |
Primary outcome
Proportion of Well-Tolerated Venipuncture
Time frame: During intravenous cannulation in the operating room
The proportion of children with well-tolerated venipuncture during intravenous cannulation, assessed using the Children's Fear Scale (CFS), a validated 5-point scale ranging from 0 to 4 (0 = no fear; 4 = extreme fear). Well-tolerated venipuncture is defined as a CFS score < 3 at the time of the venipuncture attempt.
2 secondary outcomes
Anxiety Scores
Time frame: Assessed preoperatively before oral premedication and after premedication in the preoperative holding area.
Pain Scores During Venipuncture
Time frame: During intravenous cannulation in the operating room
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 28 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Midazolam Premedication, Oral Midazolam plus Ibuprofen Premedication and Oral Midazolam plus Ketamine Premedication in people with Pediatric Anesthesia and Premedication, run by Diskapi Yildirim Beyazit Education 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 6 inclusion and 6 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 28 Jul 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 Elif Şule Özdemir Sezgi (00905059209638, elifsule-91@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Well-Tolerated Venipuncture (time frame: During intravenous cannulation in the operating room). 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 28 Jul 2026.