Nebulized Bupivacaine Analgesia for Cleft Palate Repair

Last updated: August 3, 2025
Sponsor: Assiut University
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

0.9% saline

Bupivacaine Hydrochloride

Clinical Study ID

NCT04928352
17300615
  • Ages 1-7
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Coronary artery disease

  • Hypertension

  • Developmental delay

  • Allergy to study drug

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: 0.9% saline
Phase: 3
Study Start date:
June 14, 2021
Estimated Completion Date:
September 20, 2026

Study 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).

Connect with a study center

  • Assiut university hospital

    Assiut, Assuit Assuit universi
    Egypt

    Active - Recruiting

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