Nebulized Bupivacaine Analgesia for Cleft Palate Repair
Recruiting
Phase 3
Interventional Study
Cleft Palate
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 – 7
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Assiut University · Other
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About This Trial
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.
Trial Locations
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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 d…
Contacts