Lidocaine Infusion for Pain Relief in Children Scheduled for Tonsillectomy and Adenoidectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lidocaine Infusions for Children Undergoing Combined Tonsillectomy and Adenoidectomy: A Double-Blinded, Randomized, Placebo-Controlled Trial

Conditions
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Children, Only, Tonsillar Hypertrophy, Adenoid Hypertrophy

Intervention / Treatment
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* Drug: Lidocaine Iv
* Drug: Saline Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - scheduled tonsillectomy and adenoidectomy with or without myringotomy/PE tubes at Hasbro Children's Hospital Exclusion Criteria: history of allergies to local anesthetics physical or developmental delays psychiatric illness current use of sedative or anticonvulsive medications use of premedication (oral/nasal) pre-existing cardiovascular, renal, or hepatic disease pre-existing cerebral or neuromuscular disease patient with personal or family history of malignant hyperthermia recent history of upper respiratory infection within last 7 days regular use of analgesic medications

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Enrolled patients will be randomly assigned into one of two intervention groups: Group 1: systemic lidocaine infusion Group 2: normal saline infusion
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>Lidocaine infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes. | Drug: Lidocaine Iv<br>* Intravenous infusion<br>|
| Placebo Comparator: Saline<br>Saline infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes. | Drug: Saline Solution<br>* Intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lidocaine, Tonsillectomy and Adenoidectomy, Pain