Lidocaine Infusions for Chronic Pain in Children

Study Overview
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Brief Summary
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This is a study to evaluate the efficacy and safety of lidocaine in the management of chronic pain in children. All participants will receive lidocaine infusion and severity of pain and degree of chronic-pain related disability will be assessed before and up to 4 weeks after infusion. Adverse events will be recorded.

Detailed Description
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Reports have shown that intravenous lidocaine infusions have been effective in relieving chronic pain that has been resistant to other therapies, with minimal side effects. The investigators would like to determine whether severity of pain and degree of chronic-pain related disability could be reduced with lidocaine infusion in children and to understand whether the dose of lidocaine correlates with blood levels in the same manner as it does in adults. The investigators will recruit 24 patients aged 8-18 with chronic pain that has not been relieved by standard therapies. Each patient will receive a lidocaine infusion over 2 hours. Blood will be drawn for lidocaine concentration before the beginning of the infusion, immediately after and 0.5, 2 and 4 hours after. Severity of pain and degree of disability will be recorded using a questionnaire measuring pain scores, sleep disruption, social disruption, physical abilities and school attendance before the infusion, weekly for 2 weeks and then 4 weeks after. This study will help the investigators better understand the effectiveness and safety of intravenous lidocaine for chronic pain in children.

Official Title
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A Pilot Study of the Effectiveness of Lidocaine Infusions for the Management of Chronic Pain in Children

Conditions
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Pain, Chronic

Intervention / Treatment
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* Drug: Lidocaine Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with a chronic pain condition (> 3 months) other conventional medical therapies (anticonvulsants, tricyclics etc), have not been effective. American Society of Anesthesiologists class 1 or 2 Age 8-18 years Ability to understand and use the numeric rating scale to rate their pain and to understand and answer other questionnaires Negative pregnancy test in participants of child-bearing potential (Females 12 years of age and older, or menarchal if under 12) Exclusion Criteria: History of seizures Known liver or renal disease Patient taking strong CYP1A2 inducers or inhibitors (fluvoxamine, phenytoin, cimetidine, amiodarone) or beta blockers (propranolol, metoprolol, nadolol) Allergy or sensitivity to lidocaine or other local anesthetic Cardiac conduction anomalies (eg. Heart block, Wolff-Parkinson-White) Serum electrolytes (potassium, sodium, magnesium or calcium) outside of reference ranges Pregnancy Withdrawal Criteria Patient or parent/guardian request Refusal to have intravenous access and serum levels drawn Inability to complete pain scores on the questionnaires (paper or electronic) at the first infusion and weekly for 2 weeks and at one month following infusion Baseline free carnitine concentration < 26 micromoles/L or total carnitine < 32 micromoles/L (reference values from SickKids Department of Pediatric Laboratory Medicine Guide to Laboratory Services)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine Infusion<br>All participants will receive intravenous lidocaine infusion of 42 mcg/kg/minute over 2 hours, for a total of 5 mg/kg. No bolus dose will be given. | Drug: Lidocaine Infusion<br>* Patients will receive lidocaine infusion of 42 micrograms/kg/minute over tow hours for a total of 5 mg/kg.<br>* Other names: Preservative Free Lidocaine Hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Pain scores will be measured using the Numeric Rating Scale | Change from baseline pain score (7 days prior to infusion) at 14 days after completion of infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic Requirement | Participants will record all analgesics used in a pain diary provided by the investigators. | Up to seven days prior to lidocaine infusion. | 
| Analgesic Requirement | Participants will record all analgesics used in a pain diary provided by the investigators. | Up to one month after lidocaine infusion | 
| Adverse Events | Participants will be monitored for adverse events including cardiac arrhythmias, hypotension, hypertension, tachycardia, metallic taste, tinnitus, lightheadedness, nausea, vomiting and headache | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthetics, Local, Lidocaine, Pediatrics, Children, Adolescents