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Nebulized Bupivacaine Analgesia for Cleft Palate Repair

NCT04928352 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-02

No results posted yet for this 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.

Conditions

  • Cleft Palate

Interventions

DRUG

Bupivacaine Hydrochloride

Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1

OTHER

0.9% saline

Preoperative nebulized same volume of saline placebo

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Omar Soliman, MD · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-14
Primary Completion
2026-08-10
Completion
2026-09-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04928352 on ClinicalTrials.gov