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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine Infusion | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Infusion | Drug | Patients will receive lidocaine infusion of 42 micrograms/kg/minute over tow hours for a total of 5 mg/kg. |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep | The Adolescent Sleep Wake Scale will be used to assess quantity and quality of sleep. | Day of the infusion, one week, two weeks and four weeks following the infusion. |
| Pain Interference | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale will be used to measure how pain interferes with the participants activities of daily living |
Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Isaac, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| Day of the infusion, one week, two weeks and four weeks following infusion. |
| School Attendance | Participants will record the number of hours of school attendance where relevant (e.g. no school holidays, no medical appointments). | Week prior to the infusion and at two and four weeks following the infusion. |