NCT07410078 Comparative Assessment of Oral Premedication Regimens in Pediatric Ambulatory Surgery
| NCT ID | NCT07410078 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Diskapi Yildirim Beyazit Education and Research Hospital |
| Condition | Pediatric Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2026-07-26 |
| Primary Completion | 2026-08-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 135 participants in total. It began in 2026-07-26 with a primary completion date of 2026-08-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07410078 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 12 Years, studying Pediatric Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07410078 currently recruiting?
Yes, NCT07410078 is actively recruiting participants. Contact the research team at elifsule-91@hotmail.com for enrollment information.
Where is the NCT07410078 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07410078 clinical trial?
NCT07410078 is sponsored by Diskapi Yildirim Beyazit Education and Research Hospital. The trial plans to enroll 135 participants.