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

M

Miray Gözde Özdemir

Status

Not yet enrolling

Conditions

Caudal Block
Fentanyl
Pediatric Delirium
Analgesia
Pediatric Urologic Surgeries

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

Male

Ages

4 months to 12 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 2 patient groups

Group 1 ( Caudal block group )
Active Comparator group
Description:
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.
Treatment:
Procedure: Group 1 ( Caudal block group )
Group 2 (Penile block and IV Fentanyl group)
Active Comparator group
Description:
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.
Treatment:
Procedure: Group 2 (Penile block and IV Fentanyl group)

Trial contacts and locations

1

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Central trial contact

Miray G Özdemir, MD

Data sourced from clinicaltrials.gov

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