A Phase 3 interventional study of Bupivacaine Hydrochloride and 0.9% saline in Cleft Palate, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 1 Year to 7 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Assiut University · Phase 3, Interventional, and Treatment
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.
A written informed consent will be taken from the guardian of children. Patients will be assigned randomly to two groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 60 patients will be allocated in two groups (of 30 patients each) to receive; Nebulized plain Bupivacaine 0.50% 0.50 mg.kg-1 (Group B) or same volume of saline placebo (Group C).
123 studies on the registry are indexed under Cleft Palate; 35 are open to participants now.
This study's planned enrollment of 60 is above the median of 44 across 77 interventional studies indexed under Cleft Palate.
Browse Cleft Palate studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Nebulized Bupivacaine 0.50% 0.50 mg.kg-1
Drug: Bupivacaine Hydrochloride
Same volume of nebulized saline placebo
Other: 0.9% saline
Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1
Also known as: marcaine
Preoperative nebulized same volume of saline placebo
Also known as: Normal saline
the total postoperative consumption of rescue analgesics
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.
Time frame: 24 hour after surgery
Postoperative FLACC score
The FLACC (Face, Legs, Activity, Cry, Consolability) is a behavioural pain assessment scale for use in non-verbal or pre-verbal patients unable to self-report their level of pain.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.
Time frame: 24 hour postoperative
The time to first request for rescue analgesics
Recording the first time when patients will receive IV paracetamol 15 mg.kg-1 as rescue analgesia if requested and if FLACC scores were ≥4.
Time frame: 24 hour postoperative
Plan to share: Undecided
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Studies of the drug tested here: Bupivacaine