Methylprednisolone Versus Dexamethasone in Pediatric Caudal Block

NCT05717374 | Unknown

• 1 other identifier: R.22.12.1971.R1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind, controlled bi-center study was designed to compare the postoperative analgesic efficacy of dexamethasone and methylprednisolone in caudal block for children undergoing hypospadias surgical repair using the duration of analgesia as the primary outcome. We hypothesize that methylprednisolone will provide superior postoperative analgesia than dexamethasone when added to bupivacaine for caudal block. This study will be conducted on 80 male patients of American Society of Anesthesiologists physical status I-II of with their age ranging from 1 to 6 years scheduled for surgical repair of hypospadias. The patients will be randomly assigned into 2 groups:- Group D: will receive 0.5 ml/kg volume (bupivacaine 0.25 % + dexamethasone 0.1mg/kg) Group M: will receive 0.5 ml/kg volume (bupivacaine 0.25% + methylprednisolone 0.5mg/kg) The main collected data will be the duration of analgesia (first need for rescue analgesia ), the severity of postoperative pain according to FLACC and the side effects like nausea and vomiting, respiratory depression.

Conditions

Caudal Block

Outcome Measures

Primary Outcomes (1)

• duration of analgesia

  first need for rescue analgesia will be recorded

  Up to 24 hours after the procedure]

Secondary Outcomes (2)

• the severity of postoperative pain according to FLACC score

  Up to 24 hours after the procedure]

• side effects

  Up to 24 hours after the procedure]

Study Arms (2)

Group Dexamethasone

ACTIVE COMPARATOR

will receive 0.5 ml/kg volume (bupivacaine 0.25 % + dexamethasone 0.1mg/kg) for caudal block

Drug: caudal block using dexamethasone

Group Methylprednisolone

EXPERIMENTAL

will receive 0.5 ml/kg volume (bupivacaine 0.25% + methylprednisolone 0.5mg/kg) for caudal block

Drug: caudal block using methylprednisolone

Interventions

caudal block using dexamethasone DRUG

patient will receive 0.5 ml/kg volume (bupivacaine 0.25 % + dexamethasone 0.1mg/kg) through the sacral hiatus

Also known as: caudal dexamethasone

Group Dexamethasone

caudal block using methylprednisolone DRUG

patients will receive 0.5 ml/kg volume (bupivacaine 0.25% + methylprednisolone 0.5mg/kg) through the sacral hiatus

Also known as: caudal methylprednisolone

Group Methylprednisolone

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male patients
• American Society of Anesthesiologists physical status I-II of
• age ranging from 1 to 6 years
• scheduled for surgical repair of hypospadias

You may not qualify if:

• a history of neurodevelopmental delay
• type I diabetes
• coagulopathy
• known allergy to any local anesthetic or steroid,
• known congenital anomaly of the spine and local infection.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Dakahlia Governorate, 3551, Egypt

RECRUITING

Central Study Contacts

Mahmoud M Alseoudy, MD

CONTACT

+201006224551; drs3ody.mansora@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Model Details: Prospective, randomized, double blind study

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 8, 2023
• Study Start: February 13, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)