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Lidocaine is widely available and is a very commonly used local anesthetic. When administered intravenously, lidocaine infusions have anti-inflammatory effects and have significantly decreased the reliance on opioid use for adequate pain management in adult abdominal and spine surgeries. A major advantage of lidocaine infusion is that it is not associated with a significant side effect profile.The role of lidocaine in pediatric acute perioperative pain remains limited.
The aim of the study is to determine if using lidocaine continuously during anesthesia care will decrease post-operative pain for children having their tonsils and adenoids removed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Active Comparator | Lidocaine infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes. |
|
| Saline | Placebo Comparator | Saline infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Iv | Drug | Intravenous infusion |
| |
| Saline Solution |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Scores | FLACC scale includes 5 categories (Face, Legs, Activity, Cry, Consolability) of pain behaviors scored from 0-2 to provide a total pain score ranging from 0 to 10 with higher numbers indicating greater or worse pain. | 15 minute intervals in postanesthesia care unit; up to 120 minutes following surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | Morphine equivalents | Total perioperative period: time in the operating room until time of discharge to home from the postoperative anesthesia care unit (PACU) |
| Emergence delirium scores |
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Inclusion Criteria:
- scheduled tonsillectomy and adenoidectomy with or without myringotomy/PE tubes at Hasbro Children's Hospital
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Suh, MD | Lifespan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasbro Children's Hospital | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24510234 | Background | Guntinas-Lichius O, Volk GF, Geissler K, Komann M, Meissner W. Pain after pediatric otorhinolaryngologic surgery: a prospective multi-center trial. Eur Arch Otorhinolaryngol. 2014 Jul;271(7):2049-60. doi: 10.1007/s00405-014-2914-9. Epub 2014 Feb 9. | |
| 24393224 | Background | Howard D, Davis KF, Phillips E, Ryan E, Scalford D, Flynn-Roth R, Ely E. Pain management for pediatric tonsillectomy: an integrative review through the perioperative and home experience. J Spec Pediatr Nurs. 2014 Jan;19(1):5-16. doi: 10.1111/jspn.12048. Epub 2013 Aug 21. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Enrolled patients will be randomly assigned into one of two intervention groups:
Group 1: systemic lidocaine infusion Group 2: normal saline infusion
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Anesthesia care providers will be acquiring the study solution from the institution's pharmacy (lidocaine or saline) to administer perioperatively. The pharmacy will prepare the study solutions per randomization and label the solution as the study solution without reference to lidocaine or saline. Per protocol, the care providers will then administer the study solution as a weight based infusion.
| Drug |
Intravenous infusion |
|
Pediatric Anesthesia Emergence Delirium (PAED) scale to differentiate emergence delirium from postoperative pain. The scale includes 5 categories (eye contact, purposefulness of actions, awareness of surroundings, restlessness, inconsolable) each scored from 0 to 4 to provide a total score ranging from 0 to 20 with higher numbers being worse indicating that the emergence behaviors correlate better with emergence delirium.
| 5 minute intervals for the first 30 minutes in postanesthesia care unit, then every 15 minutes for an additional 90 minutes after surgery |
| Parental satisfaction with the anesthetic | Measured on a scale from 0 to 10, where 0 means very unsatisfied and 10 means very satisfied; higher numbers are better | Evaluated once on postoperative day 1 (or 24 hours after surgery) |
| 10692621 | Background | Koppert W, Ostermeier N, Sittl R, Weidner C, Schmelz M. Low-dose lidocaine reduces secondary hyperalgesia by a central mode of action. Pain. 2000 Mar;85(1-2):217-24. doi: 10.1016/s0304-3959(99)00268-7. |
| 21061107 | Background | Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0. |