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Clinical trial

Dexmedetomidine as an Adjuvant to Bupivacaine in Unilateral Transversus Abdominis Plane Block in Pediatrics

ID
Name
274:7/2019
Description
the present study was designed to compare the efficacy and safety of two different doses of dexmedetomidine as an adjuvant to bupivacaine in unilateral TAP block in pediatric patients undergoing lower abdominal surgery.
Trial arms
Trial start
2019-08-01
Estimated PCD
2020-12-26
Trial end
2020-12-30
Status
Completed
Treatment
Bupivacain
We will carry out the TAP block using 0.5 ml/ kg bupivacaine 0.25%
Arms:
Control group
Dexmedetomidine o.5 μg
We will carry out the TAP block using using 0.5 ml/ kg bupivacaine 0.25% with dexmedetomidine 0.5 μg / kg
Arms:
Dexmedetomidine 0.5 μg group
Dexmedetomidine 1 μg
We will carry out the TAP block using using 0.5 ml/ kg bupivacaine 0.25% with dexmedetomidine 1 μg / kg
Arms:
Dexmedetomidine 1 μg group
Size
90
Primary endpoint
Quality of analgesia
24 hours after block
Eligibility criteria
Inclusion Criteria: * ASA class I or II, aged from 1-7 years old undergoing any lower abdominal surgery that requires skin incision in one side of midline of the anterior abdominal wall Exclusion Criteria: * Participants refusing regional block and those having bleeding disorders, skin lesions or wounds at the site of proposed needle insertion, evidence of peritonitis, septicemia and hepatic disease or enlargement in addition to those who required emergency procedures or operations that requires exploratory longitudinal midline incision were excluded from the study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}
Updated at
2023-08-01

1 organization

2 products

1 indication

Organization
Minia University
Product
Bupivacain
Indication
Transversus Abdominis Plane Block
Product
Dexmedetomidine