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Lidocaine Infusions for Chronic Pain in Children

CompletedPhase 3NCT02983682
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

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.

Study details

Official title
A Pilot Study of the Effectiveness of Lidocaine Infusions for the Management of Chronic Pain in Children
Conditions
Interventions
  • Drug: Lidocaine Infusion
Sponsor
The Hospital for Sick Children
Start date
2017-01
Primary completion
2023-12
Sex
All
Age range
from 8 Years to 18 Years
Results posted
No results posted in this snapshot
Countries
Canada
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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")

Canadian sites (1)

FacilityCityProvince
The Hospital for Sick ChildrenTorontoOntario

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02983682