Nebulized Bupivacaine Analgesia for Cleft Palate Repair
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- STATUS
- Recruiting
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- End date
- Nov 15, 2023
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- participants needed
- 90
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- sponsor
- Assiut University
Summary
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.
Description
A written informed consent will be taken from the guardian of children. Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 90 patients will be allocated in three groups (of 30 patients each) to receive; Nebulized Bupivacaine 0.50% 0.25 mg.kg-1 (Group B1) or Nebulized Bupivacaine 0.50% 0.50 mg.kg-1 (Group B2) or same volume of saline placebo (Group C).
Details
| Condition | Cleft Palate |
|---|---|
| Treatment | 0.9% saline, Bupivacaine Hydrochloride |
| Clinical Study Identifier | NCT04928352 |
| Sponsor | Assiut University |
| Last Modified on | 24 April 2022 |
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