RecruitingPhase 3NCT04928352
Nebulized Bupivacaine Analgesia for Cleft Palate Repair
Preemptive Nebulized Bupivacaine for Pain Control After Cleft Palate Repair in Children: A Randomized Double Blind Controlled Trial
Sponsor
Assiut University
Enrollment
60 participants
Start Date
Jun 14, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
In this study we introduce a potent local anesthetic; bupivacaine 0.5% in 0.5 mg/kg dose by nebulization as a preemptive analgesia to compare efficacy and safety in children with cleft palate repair.
Eligibility
Min Age: 1 YearMax Age: 7 Years
Inclusion Criteria2
- 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 Criteria4
- Coronary artery disease
- Hypertension
- Developmental delay
- Allergy to study drug
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Interventions
DRUGBupivacaine Hydrochloride
Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1
OTHER0.9% saline
Preoperative nebulized same volume of saline placebo
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04928352
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