Oral Premedication Choices to Help Kids Tolerate Venipuncture in Day-Case Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, three-arm interventional study compares oral midazolam alone, midazolam with ibuprofen, and midazolam with ketamine in children undergoing elective day-case surgery. The primary outcome is the rate of well-tolerated venipuncture using behavioral and pain scales. Secondary outcomes include anxiety levels, venipuncture success metrics, time to IV access, and satisfaction from parents and anesthesiologists. A predefined rescue inhalational induction protocol is available if premedication is inadequate or venous access fails. The aim is to identify premedication regimens that improve cooperation and reduce distress during venous cannulation in pediatric anesthesia.

Why it matters

Who can join: the full rules

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

Where it's running

• Ankara Etlik City Hospital
  Ankara, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Elif Şule Özdemir Sezgi
• Email: elifsule-91@hotmail.com
• Phone: 00905059209638

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.