[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07552766":3,"trial-entities:NCT07552766":155,"trial-summary:NCT07552766":159},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":46,"secondary_outcomes":51,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":86,"locations":89,"central_contacts":108,"overall_officials":115,"references":116,"see_also_links":154},"NCT07552766","STUDY00000497","A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements","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","RECRUITING","2029-07","2026-04","2026-07-06","2026-06-24","Nemours Children's Clinic","OTHER",true,"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.\n\nAll 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, rescue antiemetic use and the relationship between infusion duration and outcomes.\n\nPatients will be closely monitored for signs of local anesthetic systemic toxicity and other adverse events. The goal of this study is to determine whether IV lidocaine is an effective opioid-sparing adjunct in pediatric orthopedic surgery and to support safer, multimodal analgesia strategies.",null,[19,20,21,22,23,24,25],"Fracture Arm","Fracture Closed of Lower End of Forearm, Unspecified","Fracture Elbow","Fracture Fixation","Fracture Fixation, Internal","Fracture Forearm","Fracture Distal Radius",[],"INTERVENTIONAL","TREATMENT",[30],"PHASE4",{"count":32,"type":33},90,"ESTIMATED",[35,41],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DRUG","Lidocaine Infusion","Patients will be randomized to receive either lidocaine infusion or placebo intraoperatively. Perioperative opioid requirements will be compared between the two groups.",[40],"Patients receiving lidocaine infusion",{"type":14,"name":42,"description":43,"armGroupLabels":44},"Standard of Care (SOC)","Standard of care",[45],"Patients receiving placebo",[47],{"measure":48,"description":49,"timeFrame":50},"Total perioperative opioid consumption","Determine the effect of IVLI on intraoperative and postoperative opioid consumption in pediatric patients undergoing orthopedic surgery for long bone fractures of the upper extremity","60 minutes after patient arrival to post-anesthesia care unit (PACU)",[52,56,60],{"measure":53,"description":54,"timeFrame":55},"Postoperative pain scores","The maximum postoperative pain scores in patients who received IVLI will be equivalent or less than patients who received placebo in PACU at 30, 60, and 90 minutes and the time when patient meets Phase 1 PACU discharge criteria.","30, 60, 90 minutes and the time when patient meets Phase 1 PACU discharge criteria.",{"measure":57,"description":58,"timeFrame":59},"Rescue Anti-Emetic Use","Assess the effect of IVLI on rescue anti-emetic use and Phase 1 PACU length of stay.","Duration of Phase 1 PACU length of stay",{"measure":61,"description":62,"timeFrame":63},"Infusion and Surgical Length","Evaluate if the infusion time of IVLI impacts post-operative opioid consumption and post- operative pain scores. Hypothesis: Patients who receive IVLI for \\> 2 hours will have lower post- operative opioid requirements and post-operative pain scores than patients who receive the infusion for \\\u003C 2 hours.","60 minutes after patient arrives in post-anesthesia care unit (PACU)","ALL","3 Years","18 Years",false,{"inclusion":69,"exclusion":73,"raw_text":85},[70,71,72],"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",[74,75,76,77,78,79,80,81,82,83,84],"Children \\\u003C 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","Inclusion Criteria:\n\n* Patients aged 3-18 years\n* Patients \\> 10 kg\n* 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\n\nExclusion Criteria:\n\n* Children \\\u003C 3 years or \\> 18 years\n* Patients with allergy to local anesthetics\n* Patients who are eligible for an receive a peripheral nerve block\n* Patients with multi-trauma or open fractures\n* Patients with previous history of seizure disorder\n* Patients with conduction abnormalities or cardiac arrhythmia requiring chronic treatment\n* Patients on strong CYP450 inhibitors (fluvoxamine, erythromycin, ciprofloxacin, rifampin, allopurinol, ketoconazole, itraconazole)\n* Patients with chronic kidney or liver dysfunction\n* Patients with planned use of continuous infusion pain medications (opioids, ketamine, alpha-2- agonists)\n* Patients with positive pregnancy test prior to surgery or nursing mothers\n* Patients who parents decline enrollment",[87,88],"CHILD","ADULT",[90],{"facility":91,"status":8,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":105},"Nemours Children's Hospital","Wilmington","Delaware","19803","United States",[97,102],{"name":98,"role":99,"phone":100,"email":101},"Isabela Santiago","CONTACT","302-577-0126","isabela.santiago@nemours.org",{"name":103,"role":104},"Angela Snow, MR","PRINCIPAL_INVESTIGATOR",{"lat":106,"lon":107},39.74595,-75.54659,[109,113],{"name":110,"role":99,"phone":111,"email":112},"Angela Snow, MD","302-824-1792","angela.snow@nemours.org",{"name":114,"role":99,"phone":100,"email":101},"Isabela Santiago, BS",[],[117,121,124,127,130,133,136,139,142,145,148,151],{"pmid":118,"type":119,"citation":120},"36424875","BACKGROUND","Heath C, Hii J, Thalayasingam P, von Ungern-Sternberg BS, Sommerfield D. Perioperative intravenous lidocaine use in children. Paediatr Anaesth. 2023 May;33(5):336-346. doi: 10.1111\u002Fpan.14608. Epub 2022 Dec 4.",{"pmid":122,"type":119,"citation":123},"39076006","Pardessus P, Loiselle M, Brouns K, Horlin AL, Bruneau B, Maroun Y, Lagarde M, Deliere M, Julien-Marsollier F, Dahmani S. Intravenous lidocaine for postoperative analgesia management in paediatrics: A systematic review with meta-analysis of published studies. Eur J Anaesthesiol. 2024 Nov 1;41(11):856-864. doi: 10.1097\u002FEJA.0000000000002046. Epub 2024 Jul 29.",{"pmid":125,"type":119,"citation":126},"39365287","Gupta A, Ashok V. Perioperative intravenous lignocaine for pediatric postoperative pain-A systematic review and meta-analysis. Paediatr Anaesth. 2025 Jan;35(1):25-32. doi: 10.1111\u002Fpan.15015. Epub 2024 Oct 4.",{"pmid":128,"type":119,"citation":129},"33397287","Kaszynski M, Lewandowska D, Sawicki P, Wojcieszak P, Pagowska-Klimek I. Efficacy of intravenous lidocaine infusions for pain relief in children undergoing laparoscopic appendectomy: a randomized controlled trial. BMC Anesthesiol. 2021 Jan 5;21(1):2. doi: 10.1186\u002Fs12871-020-01218-0.",{"pmid":131,"type":119,"citation":132},"34036532","Hall EA, Sauer HE, Davis MS, Anghelescu DL. Lidocaine Infusions for Pain Management in Pediatrics. Paediatr Drugs. 2021 Jul;23(4):349-359. doi: 10.1007\u002Fs40272-021-00454-2. Epub 2021 May 26.",{"pmid":134,"type":119,"citation":135},"33633427","Chu R, Umukoro N, Greer T, Roberts J, Adekoya P, Odonkor CA, Hagedorn JM, Olatoye D, Urits I, Orhurhu MS, Umukoro P, Viswanath O, Hasoon J, Kaye AD, Orhurhu V. Intravenous Lidocaine Infusion for the Management of Early Postoperative Pain: A Comprehensive Review of Controlled Trials. Psychopharmacol Bull. 2020 Oct 15;50(4 Suppl 1):216-259. doi: 10.64719\u002Fpb.4391.",{"pmid":137,"type":119,"citation":138},"3954094","Finholt DA, Stirt JA, DiFazio CA, Moscicki JC. Lidocaine pharmacokinetics in children during general anesthesia. Anesth Analg. 1986 Mar;65(3):279-82.",{"pmid":140,"type":119,"citation":141},"14715049","Mazoit JX, Dalens BJ. Pharmacokinetics of local anaesthetics in infants and children. Clin Pharmacokinet. 2004;43(1):17-32. doi: 10.2165\u002F00003088-200443010-00002.",{"pmid":143,"type":119,"citation":144},"40021547","Foong KW, Loh PS, Chaw SH, Lo YL. Population Pharmacokinetics of IV Lidocaine and its Metabolites in Adult Surgical Patients. Pharm Res. 2025 Mar;42(3):451-473. doi: 10.1007\u002Fs11095-025-03835-1. Epub 2025 Feb 28.",{"pmid":146,"type":119,"citation":147},"6863582","Ochs HR, Knuchel M, Abernethy DR, Greenblatt DJ. Dose-independent pharmacokinetics of intravenous lidocaine in humans. J Clin Pharmacol. 1983 Apr;23(4):186-8. doi: 10.1002\u002Fj.1552-4604.1983.tb02723.x. No abstract available.",{"pmid":149,"type":119,"citation":150},"27199310","Weibel S, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Afshari A, Kranke P. Efficacy and safety of intravenous lidocaine for postoperative analgesia and recovery after surgery: a systematic review with trial sequential analysis. Br J Anaesth. 2016 Jun;116(6):770-83. doi: 10.1093\u002Fbja\u002Faew101.",{"pmid":152,"type":119,"citation":153},"34516466","Keil LG, Sullivan MH, Dadoo S, Stillwagon MR, Vergun AD. How Much Opioid Do Kids Actually Need? A Prospective Study of Analgesic Prescribing and Postdischarge Opioid Use Among Pediatric Patients With Operative Fractures. J Pediatr Orthop. 2021 Nov-Dec 01;41(10):e871-e876. doi: 10.1097\u002FBPO.0000000000001965.",[],{"nct_id":4,"conditions":156,"biomarkers":158},[157],"Arm Fracture",[],{"nct_id":4,"found":15,"summary":160,"prompt_version":170},{"design":161,"status":162,"heading":163,"summary":164,"follow_up":165,"word_count":166,"commitments":167,"compensation":168,"drugs_mentioned":169},"This is a randomized, double-blind study, meaning participants are randomly assigned to receive either lidocaine or a placebo, and neither you nor your doctors will know which you are receiving. The study plans to enroll 90 participants.","completed","Lidocaine Infusion for Pain Control in Pediatric Arm Fracture Surgery","This study is looking at whether giving lidocaine (a numbing medicine) through an IV during surgery for arm fractures in children can help reduce the amount of pain medication (opioids) they need. Children aged 3 to 18 years old who are having surgery for an upper arm fracture at Nemours Children's Hospital - Delaware Valley might be able to join. Half of the participants will receive lidocaine during surgery, and the other half will receive a placebo (inactive substance). The main goal is to see if the lidocaine group uses less opioid pain medicine within 60 minutes after waking up from surgery. The study plans to enroll 90 children.","Your opioid consumption will be measured up to 60 minutes after arriving in the post-anesthesia care unit (PACU).",109,"You would receive either lidocaine or a placebo during your surgery. Your pain and opioid use will be measured during and after surgery.","Not stated in the trial record.",[],"v2"]