Clinical trial

Efficacy and Safety of Methylprednisolone Versus Dexamethasone in Caudal Block for Children Undergoing Hypospadias Surgical Repair: A Bi-center Randomized Controlled Study

Name
R.22.12.1971.R1
Description
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.
Trial arms
Trial start
2023-02-13
Estimated PCD
2023-11-01
Trial end
2023-12-01
Status
Recruiting
Treatment
caudal block using dexamethasone
patient will receive 0.5 ml/kg volume (bupivacaine 0.25 % + dexamethasone 0.1mg/kg) through the sacral hiatus
Arms:
Group Dexamethasone
Other names:
caudal dexamethasone
caudal block using methylprednisolone
patients will receive 0.5 ml/kg volume (bupivacaine 0.25% + methylprednisolone 0.5mg/kg) through the sacral hiatus
Arms:
Group Methylprednisolone
Other names:
caudal methylprednisolone
Size
80
Primary endpoint
duration of analgesia
Up to 24 hours after the procedure]
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, double blind study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-02-15

1 organization

2 products

1 indication

Indication
caudal block