Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04928352 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Nebulized Bupivacaine Analgesia for Cleft Palate Repair

StatusRecruiting
PhasePhase 3
Started2021-06-14
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Aug 10, 2026 → Nov 10, 2026
See other at-risk trials from Assiut University

Amendment history

2026-09-04
Study Status v9
Primary completion pushed: 2026-08-10 → 2026-11-10
Completion pushed: 2026-09-20 → 2026-11-20
2025-12-27
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures v8
Enrollment target90→60
Study arms3→2
Interventions0.9% saline (Other), Bupivacaine Hydrochloride (Drug), Bupivacaine Hydrochloride (Drug)→0.9% saline (Other), Bupivacaine Hydrochloride (Drug)
Secondary endpointsdetails revised at 2 of 2 entries
Study description-54 characters
A written informed consent will be taken from the guardian of children. Patients will be assigned randomly to threetwo groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 9060 patients will be allocated in threetwo groups (of 30 patients each) to receive; Nebulized Bupivacaine 0.50% 0.25 mg.kg-1 (Group B1) or Nebulizedplain Bupivacaine 0.50% 0.50 mg.kg-1 (Group B2B) or same volume of saline placebo (Group C).
2025-08-03
Study Status v7
Primary completion date2025-06-10→2026-08-10
Completion date2025-06-20→2026-09-20
2024-07-30
Study Status v6
Primary completion date2024-06-10→2025-06-10
Completion date2024-06-20→2025-06-20
2024-05-16
Study Status v5
Re-verified, no change to tracked fields
Show 4 earlier versions
2023-04-11
Study Status v4
Primary completion date2023-10-10→2024-06-10
Completion date2023-11-15→2024-06-20
2022-03-27
Study Status v3
Primary completion date2021-10-10→2023-10-10
Completion date2021-11-15→2023-11-15
2021-08-24
Study Status v2
Primary completion date2021-08-10→2021-10-10
Completion date2021-08-15→2021-11-15
2021-06-18
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2021-06-10
Original filing
Assiut University
1,604 trials monitored
See 18 trials at risk
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.
Trial Details
NCT Number NCT04928352
Lead Sponsor Assiut University
Conditions Cleft Palate
Enrollment 60 participants
Start Date 2021-06-14
Primary Completion 2026-11-10 (estimated)
Study Completion 2026-11-20 (estimated)
Updated on ClinicalTrials.gov 2026-09-09