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

NCT06862271 | Not Yet Recruiting

• 1 other identifier: 102
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pediatric urologic surgeries; pediatric delirium; caudal block; penile block; FLACC Scale; PAED Scale

Outcome Measures

Primary Outcomes (1)

• Pediatric Anesthesia Emergence Delirium (PAED) Scale

  The PAED scale will be used to assess post-anesthesia emergence agitation. This scale was defined in 2004 and is considered the standard for diagnosing emergence agitation. The scale, consisting of five statements (from "child makes eye contact" to "child cannot be comforted") is rated from 1 to 4, with a maximum score of 20. Patients are observed for each of the 5 symptoms of delirium. After an observation is completed, the clinician subjectively scores the severity of that delirium symptom using the Lickert scale ("not at all," "only a little," "quite a bit," "very much," and "extremely"). A total score of 10 or more may be consistent with delirium urgent. As the score increases, a score of ≥10 points indicates 64% sensitivity and 86% specificity for delirium, while a score of \>12 points provides 100% sensitivity and 94.5% specificity for the diagnosis of emergency delirium (ED).

  The first evaluation will be made after extubation, the second evaluation will be made at the 15th minute after surgery.

Secondary Outcomes (2)

• Face Leg Activity Cry Consolability (FLACC) Scale

  The first evaluation will be made after extubation, the second evaluation will be made at the 15th minute after surgery.

• LİKERT Scale

  24th hour after surgery

Study Arms (2)

Group 1 ( Caudal block group )

ACTIVE COMPARATOR

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.

Procedure: Group 1 ( Caudal block group )

Group 2 (Penile block and IV Fentanyl group)

ACTIVE COMPARATOR

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.

Procedure: Group 2 (Penile block and IV Fentanyl group)

Interventions

Group 1 ( Caudal block group ) PROCEDURE

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.

Group 1 ( Caudal block group )

Group 2 (Penile block and IV Fentanyl group) PROCEDURE

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.

Group 2 (Penile block and IV Fentanyl group)

Eligibility Criteria

• Age: 4 Months - 12 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• months - 12 years old male patient
• Acceptance of participation in the study
• Patients Planned for Urogenital Surgery
• ASA I-II Patients

You may not qualify if:

• \<4 months, \>12 years male patient
• Female patient
• Not accepted to be included in the study
• ASA status III-IV
• History of bleeding disorder
• Spinal cord disease
• Obstructive sleep apnea
• Developmental delay
• Behavioral disorder
• Allergy to any drug in the protocol

Sponsors & Collaborators

• Miray Gözde Özdemir: lead

Study Sites (1)

Ankara Etlik City Hospital

Yenimahalle, Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Miray G Özdemir, MD

CONTACT

+905347816151; miraygozdebinzet@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist / Doctor

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 6, 2025
• Study Start: April 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 15, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)