NCT06862271

Comparison of Caudal Block Combined With General Anesthesia and Penile Block and Intravenous Fentanyl in Pediatric Surgeries

Comparison of Postoperative Analgesia, Delirium, and Parental Satisfaction Between Caudal Block Combined With General Anesthesia and Penile Block and Intravenous Fentanyl in Pediatric Urogenital Surgeries

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Miray Gözde Özdemir · Other Government
• Sex: Male
• Age: 4 Months – 12 Years
• Healthy volunteers: Accepted

Summary

Urogenital surgery is one of the most frequently performed surgical procedures in the pediatric patient population. There is no consensus on which analgesic method is most effective for pain control in these patients. In clinical practice, if there are no contraindications, caudal block or penile block combined with intravenous fentanyl can be preferred as an analgesic method. In this study, the results of these two analgesia methods will be compared with the research.Randomly selected participants will be compared by looking at parameters such as postoperative questionnaire results, walking time and urination time.

Conditions

• Caudal Block
• Pediatric Urologic Surgeries
• Fentanyl
• Pediatric Delirium
• Analgesia

Interventions

Type	Name	Description
PROCEDURE	Group 1 ( Caudal block group )	In the caudal block group, after the induction of caudal block with investigations, 0.2% bupivacaine will be applied to the epidural space in a volume of 0.8 mL/kg and a maximum of 20 mL will be injected into the epidural space and the surgical incision will be made at the 15th minute. For participants after surgery, Pediatric Anesthesia Emergence Delirium (PAED), Face Leg Activity Cry Consolability (FLACC) scales will be recorded, and for parental satisfaction, the LIKERT scale will be used. In addition, the child's walking time, first urination time, and need for additional painkillers will be questioned and recorded.
PROCEDURE	Group 2 (Penile block and IV Fentanyl group)	In the penile block and IV fentanyl group, 1 µg/kg fentanyl will be administered by the investigations and 5 minutes later, penile block will be performed using 0.25% bupivacaine at a dose of 0.2 mL/kg. For participants after surgery, Pediatric Anesthesia Emergence Delirium (PAED), Face Leg Activity Cry Consolability (FLACC) scales will be recorded, and for parental satisfaction, the LIKERT scale will be used. In addition, the child's walking time, first urination time, and need for additional painkillers will be questioned and recorded.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-06-30
• Completion: 2025-07-15
• First posted: 2025-03-06
• Last updated: 2025-03-11

Locations

1 site across 1 country: Turkey (Türkiye)