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Clinical Trials in Egypt / NCT04928352
Recruiting Phase 3

Nebulized Bupivacaine Analgesia for Cleft Palate Repair

NCT04928352 · tracked via the Priya Life Science Egypt tracker
Sponsor
Assiut University
Phase
Phase 3
Started
2021-06-14
Last updated
2026-09-09

Condition(s) studied

Cleft Palate

Investigational drug(s) / intervention(s)

Bupivacaine Hydrochloride →0.9% saline

Bupivacaine Hydrochloride: Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1

0.9% saline: Preoperative nebulized same volume of saline placebo

Study 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

Sex
ALL
Min age
1 Year
Max age
7 Years
Healthy volunteers
No
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 drug

Primary outcome measure(s)

  • the total postoperative consumption of rescue analgesics — 24 hour after surgery
    Patients will receive IV paracetamol 15 mg.kg-1 as rescue analgesia if requested and if FLACC scores were ≥4. The FLACC (Face, Legs, Activity, Cry, Consolability). We rate the child in each of the five measurement categories, add together, and document total pain score (0 - 10) where 0= relaxed and no pain, 1-3= mild pain/discomfort, 4-6= moderate pain, 7-10= severe discomfort/pain. The scale will be recorded on admission to PACU (baseline), and at 30 minutes, 1, 3, 6, 12 and 24 hour postoperative.

Trial sites (1)

FacilityCityRegionStatus
Assiut university hospital Asyut Assuit Recruiting

More Assiut University trials in Egypt

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Intraoperative Lidocaine Infusion Starting soon

Other trials for the same condition

Role of Plasma Rich Growth Factor in Repair Primary Cleft Palate Starting soon
Effect of Furlow Palatoplasty With Buccal Myomucosal Flap on the Speech Development Recruiting
MRI Assessment of Velopharyngeal Anatomy After Modified Furlow-Buccinator Flap in Late Primary Palate Repair Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04928352 on ClinicalTrials.gov ↗ ← All trials in Egypt