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Clinical trial

Preemptive Nebulized Bupivacaine for Pain Control After Cleft Palate Repair in Children: A Randomized Double Blind Controlled Trial

ID
Name
17300615
Description
In this study we introduce a potent local anesthetic; bupivacaine 0.5% in two different doses by nebulization as a preemptive analgesia to compare efficacy and safety in children with cleft palate repair.
Trial arms
Trial start
2021-06-14
Estimated PCD
2024-06-10
Trial end
2024-06-20
Status
Recruiting
Phase
Early phase I
Treatment
Bupivacaine Hydrochloride
Preoperative Nebulized Bupivacaine 0.50% 0.25 mg.kg-1
Arms:
Group B1
Other names:
marcaine
Bupivacaine Hydrochloride
Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1
Arms:
Group B2
Other names:
marcaine
0.9% saline
Preoperative nebulized same volume of saline placebo
Arms:
Group C
Other names:
Normal saline
Size
90
Primary endpoint
the total postoperative consumption of rescue analgesics
24 hour after surgery
Eligibility criteria
Inclusion Criteria: * Children (age 1-7 years) of American Society of Anaesthesiologists physical status (ASA) I-II * Elective cleft palate repair ± cleft lip surgery under general anesthesia . Exclusion Criteria: * Coronary artery disease * Hypertension * Developmental delay * Allergy to study drug
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2024-05-17

1 organization

1 product

1 indication

Organization
Assiut University
Product
Bupivacaine
Indication
Cleft Palate