RecruitingNot ApplicableNCT07410078

Comparative Assessment of Oral Premedication Regimens in Pediatric Ambulatory Surgery

A Comparative Evaluation of Oral Premedication Regimens in Pediatric Patients Undergoing Ambulatory Surgery


Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Enrollment

135 participants

Start Date

Jul 26, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 4 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Oral Midazolam Premedication, a procedure called Oral Midazolam plus Ibuprofen Premedication, and others for people with pediatric anesthesia and premedication. The study is currently recruiting participants at 1 location. People eligible for this study include aged 4 Years to 12 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREOral Midazolam Premedication

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.

PROCEDUREOral Midazolam plus Ibuprofen Premedication

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.

PROCEDUREOral Midazolam plus Ketamine Premedication

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.


Locations(1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

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NCT07410078


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