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NCT Number: NCT07410078

Comparative Assessment of Oral Premedication Regimens in Pediatric Ambulatory Surgery

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.

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Key information

Conditions

Pediatric Anesthesia Anxiety Disorders Mental Disorders Premedication

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Midazolam Premedication

Procedure

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.

Oral Midazolam plus Ibuprofen Premedication

Procedure

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.

Oral Midazolam plus Ketamine Premedication

Procedure

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.

Primary outcomes

  1. Proportion of Well-Tolerated Venipuncture

    Time frame: During intravenous cannulation in the operating room

    The proportion of children with well-tolerated venipuncture during intravenous cannulation, assessed using the Children's Fear Scale (CFS), a validated 5-point scale ranging from 0 to 4 (0 = no fear; 4 = extreme fear). Well-tolerated venipuncture is defined as a CFS score < 3 at the time of the venipuncture attempt.

Secondary outcomes

  1. Anxiety Scores

    Time frame: Assessed preoperatively before oral premedication and after premedication in the preoperative holding area.

    The mYPAS is an observational behavioral scale consisting of five domains (activity, vocalization, emotional expressivity, state of arousal, and use of parents). Scores are calculated using the original weighted scoring algorithm and generate a standardized total score ranging from 23.3 to 100, with higher scores indicating greater anxiety.

    Clinically significant anxiety is defined as mYPAS ≥ 30.

  2. Pain Scores During Venipuncture

    Time frame: During intravenous cannulation in the operating room

    Pain intensity assessed using the Wong-Baker Faces Pain Rating Scale, a validated 6-face scale scored from 0 to 10:

    0 = no pain 10 = worst pain imaginable Higher scores indicate greater pain intensity.

Study contacts

Contact information is provided by the study sponsor or research team.

Aslı Dönmez

CONTACT

[email protected]

00905322256473

Elif Şule Özdemir Sezgi

CONTACT

[email protected]

00905059209638

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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