Actively Recruiting
Study of Intravenous Lidocaine to Reduce Opioid Use During Surgery for Children Ages 3 to 18 With Upper Arm Bone Fractures
Led by Nemours Children's Clinic · Updated on 2026-07-06
90
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether giving children intravenous lidocaine during surgery can reduce the amount of opioid pain medicine needed and improve pain control after surgery. This randomized, double-blind trial involves children aged 3 to 18 years undergoing surgery to fix upper arm bone fractures under general anesthesia. The study aims to find safer ways to manage pain using fewer opioids during pediatric orthopedic procedures. Participants will be randomly assigned to receive either a lidocaine infusion or a placebo normal saline during their surgery. All children will receive standard anesthesia and pain care afterward. The study will compare total opioid use within 60 minutes after arrival in the recovery room between the two groups. Additional measures include pain scores at various times, length of recovery room stay, use of anti-nausea medication, and how infusion duration relates to outcomes. During the study, children will be closely watched for any side effects or signs of lidocaine toxicity. Researchers will collect data on opioid consumption and pain levels during and after surgery. The primary focus is on opioid use in the first hour after surgery. The study will continue through the recovery period, monitoring safety and effectiveness, with participation lasting from surgery through early recovery.
CONDITIONS
Brief Title
A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 3 to 18 years
- Patients weighing more than 10 kilograms
- Patients undergoing surgical fixation of upper extremity fractures from distal humerus to distal radius at Nemours Children's Hospital - Delaware Valley
You will not qualify if you...
- Children younger than 3 years or older than 18 years
- Allergy to local anesthetics
- Eligible for and receiving a peripheral nerve block
- Multi-trauma or open fractures
- History of seizure disorder
- Conduction abnormalities or cardiac arrhythmia requiring chronic treatment
- Use of strong CYP450 inhibitors (fluvoxamine, erythromycin, ciprofloxacin, rifampin, allopurinol, ketoconazole, itraconazole)
- Chronic kidney or liver dysfunction
- Planned continuous infusion pain medications (opioids, ketamine, alpha-2 agonists)
- Positive pregnancy test before surgery or nursing mothers
- Parental refusal of enrollment
Research Team
A
Angela Snow, MD
I
Isabela Santiago, BS
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