Nebulized Bupivacaine Analgesia for Cleft Palate Repair

  • End date
    Nov 15, 2023
  • participants needed
  • sponsor
    Assiut University
Updated on 24 April 2022


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.


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 (Group B1) or Nebulized Bupivacaine 0.50% 0.50 (Group B2) or same volume of saline placebo (Group C).

Condition Cleft Palate
Treatment 0.9% saline, Bupivacaine Hydrochloride
Clinical Study IdentifierNCT04928352
SponsorAssiut University
Last Modified on24 April 2022


Yes No Not Sure

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
Developmental delay
Allergy to study drug
Clear my responses

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