Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain.

Detailed Description
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The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain when compared to placebo. Participants will be in one of two arms. Those in Arm 1 will receive a lidocaine bolus and infusion throughout the initial recovery period while those in Arm 2 will receive an equal volume of normal saline. Subjects will be monitored and assessed for pain during their time in the hospital and followed up on at home for a week after the surgery. Primary outcomes will be measure of pain. Secondary outcome measures will include pain medication use, emergence delirium, incidence of laryngospasm, and side effects.

Official Title
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Intravenous Lidocaine to Decrease Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blind, Placebo Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for Tonsillectomy (with or without Adenoidectomy) with Dr. Kathleen Billings or Dr. Stephen Hoff at Lurie Children's Hospital American Society of Anesthesiology (ASA) patient classification I-III (Healthy patient to a patient with mild systemic disease) Exclusion Criteria: Physical or developmental delays Psychiatric illness Current use of sedative or anticonvulsant medications Pre-existing renal disease (ranging from stage 2 [mild] to stage 5 [end stage]) Pre-existing cardiovascular disease (including, not limited to congenital heart disease or arrythmia) Pre-existing liver disease Pre-existing cerebral or neuromuscular disease Patient or family history of Malignant Hyperthermia Recent history of upper respiratory infection within last 7 days Regular use of analgesic medication Diagnosis of severe obstructive sleep apnea requiring overnight stay for observation Other procedure scheduled in addition to tonsillectomy History of allergies to local anesthetics

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>Following intraoperative IV placement, a 1.5 mg/kg bolus does of lidocaine hydrochloride is given and is followed by a continuous infusion of 2 mg/kg/hr until discharge from the Phase 1 recovery period. | Drug: Lidocaine<br>* Intraoperative dose of intravenous lidocaine followed by an infusion until discharge from the initial recovery period.<br>* Other names: Xylocaine, Lidocaine Hydrochloride;|
| Placebo Comparator: Placebo<br>Following intraoperative IV placement, a bolus of saline is given and is followed by a continuous infusion until discharge from the Phase 1 recovery period. The volume of the bolus and rate of infusion are equivalent to that which would have been given in the experimental arm. | Drug: Saline<br>* Intraoperative dose of saline followed by an infusion until discharge from the initial recovery period.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observer Rated Pain Intensity | Observer Rated Pain Intensity will be measured using the Children's Eastern Ontario Pain Scale (CHEOPS) at regular 5 and 15 minute time intervals. | Within the immediate post-operative period (90 minutes after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Rated Pain Intensity | Patient Rated Pain Intensity will be measured using the Faces Pain Scale - Revised (FPS-R) by pointing to pictures of faces displaying a spectrum of pain at regular 5 and 15 minute time intervals. | Within the immediate post-operative period (90 minutes after surgery) | 
| Observer Rated Emergence Delirium | Observer Rated Emergence Delirium will be measured using the he Pediatric Emergence Delirium (PAED) Scale at regular 5 and 15 minute time intervals. | Within the immediate post-operative period (90 minutes after surgery) | 
| Observer Rated PACU Discharge Criteria | Observer Rated PACU Discharge Criteria will be measured using the modified Aldrete Scale at regular time intervals. | Within the immediate post-operative period (90 minutes after surgery) | 
| Parent Rated Postoperative Pain at Home | Parent Rated Postoperative Pain at Home will be measured using the Parents Postoperative Pain Measures (PPPM) questionnaire and Numerical Rating Scale to report on the intensity of their child's pain. | Every day, up to 7 days postoperatively | 
| Medication Journal | Parents will keep a journal of all pain medication given to their children to treat pain. | Every day, up to 7 days postoperatively |