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New treatment option for Cleft Palate
Official title Nebulized Bupivacaine Analgesia for Cleft Palate Repair
ClinicalTrials.gov ID: NCT04928352
What this study is testing
What is Bupivacaine Hydrochloride?
Bupivacaine Hydrochloride is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for cleft palate.
Also referred to as marcaine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 7
You may be able to join if
- 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 .
You likely can't join if
- Coronary artery disease
- Hypertension
- Developmental delay
- Allergy to study drug
The study team makes the final eligibility decision.
Where it's taking place
- Asyut, Assuit, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 7 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Asyut, Assuit, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.