Lidocaine During Surgery to See If It Lowers Opioid Use in Kids with Arm Fractures
Official title: A Prospective, Randomized, Double-blind Trial of the Impact of Intraoperative Intravenous Lidocaine Infusion on Total Opioid Requirements in Children Undergoing Surgical Fixation of Upper Extremity Long Bone Fractures Under General Anesthesia
Run by Nemours Children's Clinic · NCT07552766 · Data updated 2026-11-12
In children aged 3–18 having surgery for upper-extremity fractures, this study tests whether giving IV lidocaine during the operation reduces the amount of opioid pain medicine needed after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 1 site (Wilmington, Delaware) |
| Status | Recruiting |
| Started | June 24, 2026 |
| Main results expected | December 2028 |
| Study ends | July 2029 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07552766 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 3–18 years, >10 kg, undergoing surgical fixation of upper-extremity fractures at Nemours Children’s Hospital.
✕Probably not a fit
Children with contraindications to lidocaine, those receiving nerve blocks, or those with complex medical conditions or multiple traumas may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, double-blind trial enrolling 90 children to compare intraoperative intravenous lidocaine infusion with placebo during surgical fixation of upper-extremity long-bone fractures. All participants receive standardized anesthesia and postoperative pain care, and researchers track opioid use and pain scores from intraop through recovery, with the main focus on total opioid use 60 minutes after arrival to PACU. Secondary outcomes include opioid use at later times, pain scores, PACU stay length, use of rescue antiemetics, and how infusion duration relates to outcomes. Eligibility targets children 3–18 years old weighing more than 10 kg undergoing fixation at Nemours Children’s Hospital, excluding those with certain medical or medication conditions that could affect results.
Why it matters
Potential benefit: If lidocaine reduces opioid needs, it could improve postoperative pain control and lessen opioid exposure for children.
How similar studies have gone: Preliminary adult and pediatric data suggest IV lidocaine may reduce perioperative opioid needs, but pediatric evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 3-18 years * Patients \> 10 kg * Patients who present to Nemours Children's Hospital - Delaware Valley (NCH-DE) for surgical fixation of upper extremity fractures from distal humerus to distal radius Exclusion Criteria: * Children \< 3 years or \> 18 years * Patients with allergy to local anesthetics * Patients who are eligible for an receive a peripheral nerve block * Patients with multi-trauma or open fractures * Patients with previous history of seizure disorder * Patients with conduction abnormalities or cardiac arrhythmia requiring chronic treatment * Patients on strong CYP450 inhibitors (fluvoxamine, erythromycin, ciprofloxacin, rifampin, allopurinol, ketoconazole, itraconazole) * Patients with chronic kidney or liver dysfunction * Patients with planned use of continuous infusion pain medications (opioids, ketamine, alpha-2- agonists) * Patients with positive pregnancy test prior to surgery or nursing mothers * Patients who parents decline enrollment
Where it's running
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Nemours Children's Hospital
Wilmington, Delaware, United States Recruiting
Study contacts
- Study coordinator: Angela Snow, MD
- Email: angela.snow@nemours.org
- Phone: 302-824-1792
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.