Comparative Assessment of Oral Premedication Regimens in Pediatric Ambulatory Surgery

Diskapi Yildirim Beyazit Training and Research Hospital

Status: Not yet enrolling

Conditions: Premedication; Pediatric Anesthesia

Treatments: Procedure: Oral Midazolam Premedication; Procedure: Oral Midazolam plus Ibuprofen Premedication; Procedure: Oral Midazolam plus Ketamine Premedication

Study type: Interventional

Funder types: Other

Identifiers

NCT07410078

AEŞH-EK-2025-320

Details and patient eligibility

About

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.

Enrollment: 135 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 3 patient groups

Oral Midazolam Premedication

Active Comparator group

Description:

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.

Treatment:

Procedure: Oral Midazolam Premedication

Oral Midazolam plus Ibuprofen Premedication

Active Comparator group

Description:

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.

Treatment:

Procedure: Oral Midazolam plus Ibuprofen Premedication

Oral Midazolam plus Ketamine Premedication

Active Comparator group

Description:

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.

Treatment:

Procedure: Oral Midazolam plus Ketamine Premedication