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

May 22, 2026 updated by: Miray Gözde Özdemir

Opioid-Free Caudal Block Versus Opioid-Supplemented Dorsal Penile Nerve Block Under General Anesthesia for Postoperative Analgesia and Emergence Delirium in Pediatric Urogenital Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Yenimahalle, Ankara, Turkey (Türkiye), 06100
        • Ankara Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

4 months to 12 years old male pediatric population

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • <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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Anesthesia Emergence Delirium (PAED) Scale
Time Frame: The first evaluation will be made after extubation, the second evaluation will be made at the 15th minute after surgery.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Face Leg Activity Cry Consolability (FLACC) Scale
Time Frame: The first evaluation will be made after extubation, the second evaluation will be made at the 15th minute after surgery.

The FLACC scale will be used to assess pain. Developed as a tool for evaluating postoperative pain in children, this scale is one of the most widely known and commonly recommended pain measurement scales.

Each category in the "FLACC" (Face, Legs, Activity, Cry, Consolability) pain assessment scale is evaluated between 0-2, Total score varies between 0 and 10.

A score of 0 indicates that the child is calm and relaxed, a score of 1-3 indicates that the child is mildly disturbed, a score of 4-6 indicates that the child is in moderate pain, a score of 7-10 indicates that the child is significantly disturbed, in pain, or both.
The first evaluation will be made after extubation, the second evaluation will be made at the 15th minute after surgery.
LİKERT Scale
Time Frame: 24th hour after surgery

The LIKERT scale will be used to assess the satisfaction of the patient and his/her parents. The Likert scale is a one-dimensional scale used to collect the opinions of the participants. In our study, a 5-point Likert scale will be used. The patient will be visited after the surgery, and the satisfaction of the patient and his/her relatives in the postoperative period will be questioned. 1) Not at all satisfied 2) Somewhat satisfied 3) Moderate 4) Very satisfied, 5) Excellent

When comparing the groups, it will be evaluated that a higher LIKERT score constitutes 'better satisfaction'.
24th hour after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miray Gözde Özdemir

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

November 28, 2025

Study Completion (Actual)

December 19, 2025

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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