Clinical trial NCT02983682: Lidocaine Infusions for Chronic Pain in Children
Official title: A Pilot Study of the Effectiveness of Lidocaine Infusions for the Management of Chronic Pain in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Chronic
Keywords: Anesthetics, Local
Lidocaine
Pediatrics
Children
Adolescents
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 19
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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")

Primary outcomes:
measure: Pain Score
timeFrame: Change from baseline pain score (7 days prior to infusion) at 14 days after completion of infusion
Secondary outcomes:
measure: Analgesic Requirement
timeFrame: Up to seven days prior to lidocaine infusion.
measure: Analgesic Requirement
timeFrame: Up to one month after lidocaine infusion
measure: Adverse Events
timeFrame: intraoperative
Other outcomes:
measure: Sleep
timeFrame: Day of the infusion, one week, two weeks and four weeks following the infusion.
measure: Pain Interference
timeFrame: Day of the infusion, one week, two weeks and four weeks following infusion.
measure: School Attendance
timeFrame: Week prior to the infusion and at two and four weeks following the infusion.
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Lisa Isaac, MD
role: PRINCIPAL_INVESTIGATOR
References: