Bilateral suprazygomatic maxillary nerve block for cleft palate repair in children: a prospective, randomized, double-blind study versus placebo.
Julien Chiono, Olivier Raux, Sophie Bringuier...
https://pubmed.ncbi.nlm.nih.gov/24525630Actively Recruiting
Phase 3
Age: 1Year - 7Years
All Genders
ID04928352
Preemptive Nebulized Bupivacaine for Pain Control After Cleft Palate Repair in Children: A Randomized Double Blind Controlled Trial
Led by Assiut University · Updated on 2026-01-02
60
Participants Needed
1
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of nebulized bupivacaine, a local anesthetic, as a preemptive pain relief method for children undergoing cleft palate repair. This Phase 3 randomized, double-blind controlled trial aims to compare the safety and effectiveness of this treatment with a saline placebo in children aged 1 to 7 years. The study is sponsored by Assiut University and focuses on improving postoperative pain management in pediatric patients undergoing this surgery. Participants will be randomly assigned to one of two groups, each with 30 children. One group will receive nebulized bupivacaine at a concentration of 0.5% and a dose of 0.5 mg/kg before surgery, while the other group will receive a similar volume of nebulized saline as a placebo. Both treatments are delivered preoperatively in opaque bags labeled as "study drug" to maintain blinding. The trial is designed to carefully monitor and compare the effects of the active drug versus the placebo. Children's guardians will provide informed consent before participation. During the study, researchers will monitor the total amount of rescue pain medication used during the 24 hours following surgery, the children's pain levels using the FLACC scale, and the time until the first request for rescue analgesics. The study includes thorough safety monitoring and aims to complete follow-up assessments within the first day after surgery, providing detailed information on pain control and medication needs.
CONDITIONS
Brief Title
Nebulized Bupivacaine Analgesia for Cleft Palate Repair
Who Can Participate
Age: 1Year - 7Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children aged 1 to 7 years with physical status ASA I or II
- Scheduled for elective cleft palate repair or cleft lip surgery under general anesthesia
You will not qualify if you...
- Coronary artery disease
- Hypertension
- Developmental delay
- Allergy to study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Surgery day and immediate postoperative period
Participants receive preoperative nebulized Bupivacaine or nebulized saline placebo before cleft palate repair surgery under general anesthesia.
1 preoperative treatment visit and observation during surgery
Follow-up
Duration - 24 hours after surgery
Participants are monitored for pain control and use of rescue analgesics during the 24 hours after surgery.
Postoperative observation and assessment visits within 24 hours
Trial Site Locations
Total: 1 location
1
Assiut university hospital
Asyut, Assuit, Egypt, Assuit universi
Actively Recruiting
Loading map...
Research Team
O
Omar Soliman, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here