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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, rescue antiemetic use and the relationship between infusion duration and outcomes.
Patients 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving lidocaine infusion | Experimental |
| |
| Patients receiving placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Infusion | Drug | Patients will be randomized to receive either lidocaine infusion or placebo intraoperatively. Perioperative opioid requirements will be compared between the two groups. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Snow, MD | Contact | 302-824-1792 | angela.snow@nemours.org | |
| Isabela Santiago, BS | Contact | 302-577-0126 | isabela.santiago@nemours.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Hospital | Recruiting | Wilmington | Delaware | 19803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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/pan.14608. Epub 2022 Dec 4. | |
| 39076006 | Background | 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/EJA.0000000000002046. Epub 2024 Jul 29. |
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| Standard of Care (SOC) | Other | Standard of care |
|
| 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 |
| 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 < 2 hours. | 60 minutes after patient arrives in post-anesthesia care unit (PACU) |
| 39365287 | Background | 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/pan.15015. Epub 2024 Oct 4. |
| 33397287 | Background | 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/s12871-020-01218-0. |
| 34036532 | Background | 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/s40272-021-00454-2. Epub 2021 May 26. |
| 33633427 | Background | 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/pb.4391. |
| 3954094 | Background | Finholt DA, Stirt JA, DiFazio CA, Moscicki JC. Lidocaine pharmacokinetics in children during general anesthesia. Anesth Analg. 1986 Mar;65(3):279-82. |
| 14715049 | Background | Mazoit JX, Dalens BJ. Pharmacokinetics of local anaesthetics in infants and children. Clin Pharmacokinet. 2004;43(1):17-32. doi: 10.2165/00003088-200443010-00002. |
| 40021547 | Background | 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/s11095-025-03835-1. Epub 2025 Feb 28. |
| 6863582 | Background | 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/j.1552-4604.1983.tb02723.x. No abstract available. |
| 27199310 | Background | 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/bja/aew101. |
| 34516466 | Background | 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/BPO.0000000000001965. |
| ID | Term |
|---|---|
| D000092482 | Elbow Fractures |
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D014954 | Wrist Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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