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A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements

RecruitingPhase 4Ages 3 Years - 18 YearsAllNemours Children's Clinic
NCT07552766 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is a prospective, randomized, double-blind clinical trial evaluating whether intraoperative intravenous lidocaine infusion (IVLI) reduces opioid requirements and improves postoperative pain control in children undergoing surgical fixation of upper extremity long bone fractures under general anesthesia. Ninety pediatric patients, ages 3-18 will be enrolled and randomized 1:1 to receive either IV lidocaine or placebo (normal saline) during surgery. All participants will receive standardized anesthesia care and postoperative pain management. Opioid consumption and pain scores will be measured intraoperatively and throughout the postoperative recovery, with the primary outcome focused on total opioid use 60 minutes after arrival to the post-anesthesia care unit (PACU). Secondary outcomes include opioid use at additional time points, postoperative pain scores, PACU length of stay,

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📋 Eligibility rules (as published)
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
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What it tests

  • Lidocaine Infusion
  • Standard of Care (SOC)
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Where

1 site
Nemours Children's Hospital
Wilmington, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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