Pediatric Anesthesia, Premedication
Conditions
Keywords
Pediatric Anesthesia, Premedication, Ambulatory surgery, Venipuncture tolerance, Anxiety
Brief 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.
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.
Sponsors
Diskapi Yildirim Beyazit Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Well-Tolerated Venipuncture | 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
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Scores | 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. |
| Pain Scores During Venipuncture | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTElif Şule Özdemir Sezgi
CONTACTAslı Dönmez
Outcome results
None listed