Nebulized Bupivacaine Analgesia for Cleft Palate Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacaine Hydrochloride, 0.9% saline.
- Who it may be relevant to
- Registry conditions: Cleft Palate. Basic parameters: 1 year — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Preemptive Nebulized Bupivacaine for Pain Control After Cleft Palate Repair in Children: A Randomized Double Blind Controlled Trial
Overview
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.
Detailed description
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).
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
Primary outcome measures
- the total postoperative consumption of rescue analgesics [Time frame: 24 hour after surgery]
Secondary outcome measures (2)
- Postoperative FLACC score [Time frame: 24 hour postoperative]
- The time to first request for rescue analgesics [Time frame: 24 hour postoperative]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Assiut university hospital — Asyut
Publications
- Chiono J, Raux O, Bringuier S, Sola C, Bigorre M, Capdevila X, Dadure C. Bilateral suprazygomatic maxillary nerve block for cleft palate repair in children: a prospective, randomized, double-blind study versus placebo. Anesthesiology. 2014 Jun;120(6):1362-9. doi: 10.1097/ALN.0000000000000171. PMID 24525630
Identifiers
NCT: NCT04928352 · 17300615