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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 4 months to 12 years
• Men only
• Healthy volunteers accepted
• Child

Study population: 4 months to 12 years old male pediatric population

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

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

Being tested

Group 1 ( Caudal block group ), Group 2 (Penile block and IV Fentanyl group)

Keywords

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

Medical subject headings

Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Group 1 ( Caudal block group )Procedure or surgery

  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)Procedure or surgery

  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 being measured

The primary outcome is the main question the study is designed to answer.

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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Mar 2025
2. Study start1 Apr 2025
3. Primary completion28 Nov 2025
4. Study completion19 Dec 2025

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Caudal BlockStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.