Comparative Assessment of Oral Premedication Regimens in Pediatric Ambulatory Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral Midazolam Premedication, Oral Midazolam plus Ibuprofen Premedication, Oral Midazolam plus Ketamine Premedication.
- Who it may be relevant to
- Registry conditions: Pediatric Anesthesia, Premedication. Basic parameters: 4 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Comparative Evaluation of Oral Premedication Regimens in Pediatric Patients Undergoing Ambulatory Surgery
Overview
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.
Interventions
- Procedure Oral 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. - Procedure Oral 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. - Procedure Oral 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.
Primary outcome measures
- Proportion of Well-Tolerated Venipuncture [Time frame: During intravenous cannulation in the operating room]
Secondary outcome measures (2)
- Anxiety Scores [Time frame: Assessed preoperatively before oral premedication and after premedication in the preoperative holding area.]
- Pain Scores During Venipuncture [Time frame: During intravenous cannulation in the operating room]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Ankara Etlik City Hospital — Ankara
Identifiers
NCT: NCT07410078 · AEŞH-EK-2025-320