Pain, Chronic
Conditions
Keywords
Anesthetics, Local, Lidocaine, Pediatrics, Children, Adolescents
Brief summary
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
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.
Interventions
DRUGLidocaine Infusion
Patients will receive lidocaine infusion of 42 micrograms/kg/minute over tow hours for a total of 5 mg/kg.
Sponsors
The Hospital for Sick Children
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with a chronic pain condition (\> 3 months) other conventional medical therapies (anticonvulsants, tricyclics etc), have not been effective. 2. American Society of Anesthesiologists class 1 or 2 3. Age 8-18 years 4. Ability to understand and use the numeric rating scale to rate their pain and to understand and answer other questionnaires 5. Negative pregnancy test in participants of child-bearing potential (Females 12 years of age and older, or menarchal if under 12)
Exclusion criteria
1. History of seizures 2. Known liver or renal disease 3. Patient taking strong CYP1A2 inducers or inhibitors (fluvoxamine, phenytoin, cimetidine, amiodarone) or beta blockers (propranolol, metoprolol, nadolol) 4. Allergy or sensitivity to lidocaine or other local anesthetic 5. Cardiac conduction anomalies (eg. Heart block, Wolff-Parkinson-White) 6. Serum electrolytes (potassium, sodium, magnesium or calcium) outside of reference ranges 7. Pregnancy Withdrawal Criteria 1. Patient or parent/guardian request 2. Refusal to have intravenous access and serum levels drawn 3. 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 4. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | Change from baseline pain score (7 days prior to infusion) at 14 days after completion of infusion | Pain scores will be measured using the Numeric Rating Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Requirement | Up to seven days prior to lidocaine infusion. | Participants will record all analgesics used in a pain diary provided by the investigators. |
| Adverse Events | intraoperative | Participants will be monitored for adverse events including cardiac arrhythmias, hypotension, hypertension, tachycardia, metallic taste, tinnitus, lightheadedness, nausea, vomiting and headache |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleep | Day of the infusion, one week, two weeks and four weeks following the infusion. | The Adolescent Sleep Wake Scale will be used to assess quantity and quality of sleep. |
| Pain Interference | Day of the infusion, one week, two weeks and four weeks following infusion. | 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 |
| School Attendance | Week prior to the infusion and at two and four weeks following the infusion. | Participants will record the number of hours of school attendance where relevant (e.g. no school holidays, no medical appointments). |
Countries
Canada
Outcome results
None listed