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Comparative Assessment of Oral Premedication Regimens in Pediatric Ambulatory Surgery

RecruitingNAAges 4 Years - 12 YearsAllDiskapi Yildirim Beyazit Education and Research H…
NCT07410078 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 premedic

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📋 Eligibility rules (as published)
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
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What it tests

  • Oral Midazolam Premedication
  • Oral Midazolam plus Ibuprofen Premedication
  • Oral Midazolam plus Ketamine Premedication
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Where

1 site
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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