Methylprednisolone Versus Dexamethasone in Pediatric Caudal Block

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mansoura University
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Male patients

• American Society of Anesthesiologists physical status I-II of

• age ranging from 1 to 6 years

• scheduled for surgical repair of hypospadias

Exclusion Criteria:

• 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.