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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Midazolam Premedication | Active Comparator | 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. |
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| Oral Midazolam plus Ibuprofen Premedication | Active Comparator | 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. |
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| Oral Midazolam plus Ketamine Premedication | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Well-Tolerated Venipuncture | 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. | During intravenous cannulation in the operating room |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Scores | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elif Şule Özdemir Sezgi | Contact | 00905059209638 | elifsule-91@hotmail.com | |
| Aslı Dönmez | Contact | 00905322256473 | aslidonmez@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital | Ankara | 06000 | Turkey (Türkiye) |
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| 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. |
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| 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. |
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| Assessed preoperatively before oral premedication and after premedication in the preoperative holding area. |
| Pain Scores During Venipuncture | 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. | During intravenous cannulation in the operating room |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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