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

NCT06862271 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-03-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Miray Gözde Özdemir

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
12 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-06-30
Completion
2025-07-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06862271 on ClinicalTrials.gov