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

Not Applicable

Not yet recruiting

• Conditions: Caudal Block; Fentanyl; Pediatric Urologic Surgeries; Pediatric Delirium; Analgesia

• Registration Number: NCT06862271
• Lead Sponsor: Miray Gözde Özdemir

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-28
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-06
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Study Start: 2025-04-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pediatric Anesthesia Emergence Delirium (PAED) Scale	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).

Secondary Outcome Measures

Name	Time	Method
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.	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.
LİKERT Scale	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'.

Trial Locations

Locations (1)

Ankara Etlik City Hospital; 🇹🇷 Yenimahalle, Ankara, Turkey