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Clinical trial

UROLOGICAL SURGERIES IN CHILDREN: Comparison Between 0.25% Bupivacaine and 0.25% Bupivacaine withDexmedetomidine in the Caudal Block

ID
Name
SIUT-ERC-2021/A-258
Description
The aim of this study is to compare the duration of analgesia, sedation, and intra and postoperative hemodynamics. This drug is recently available in Pakistan. To the best of our knowledge, no published data is available in this respect in Pakistan, so this study would in turn help to fill the gap in knowledge in low-resource settings/emerging economy.
Trial arms
Trial start
2021-07-10
Estimated PCD
2021-11-15
Trial end
2021-11-20
Status
Completed
Phase
Early phase I
Treatment
Bupivacaine Hydrochloride 0.25% Injection Solution
Bupivacaine Hydrochloride 0.25% Injection Dose: 1mL/kg (milliliter per kilogram body weight)
Arms:
Bupivacaine 0.25%
Bupivacaine Hydrochloride 0.25% Injection plus Dexmedetomidine 1 microgram/kg body weight
Bupivacaine HCL 0.25% Injection plus Dexmedetomidine 1micro/kg Dose: 1 mL/kg (milliliter per kilogram body weight)
Arms:
Bupivacaine+DEX
Size
60
Primary endpoint
Post operative Pain
24 hour post operatively
Eligibility criteria
Inclusion Criteria: * ASA 1 \& 2 * elective per-urethral cystolithotripsy Exclusion Criteria: * History of developmental delay or mental retardation * Known or suspected coagulopathy * Known allergy to any of the study drugs * Any signs of infection at the site of the proposed caudal block * Any caudal anatomical deformity
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'comparative study', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-07-11

1 organization

1 product

1 indication

Organization
Sindh Institute of Urology and Transplantation
Product
Bupivacaine Hydrochloride
Indication
Postoperative Pain