Overview

Lidocaine Infusions for Chronic Pain in Children

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Hospital for Sick Children
Treatments:
Lidocaine
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 CYP1A2 substrate or inhibitors (eg. Ciprofloxacin, fluvoxamine,
clozapine, duloxetine, melatonin, propranolol, tizanidine)

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")