Lidocaine Infusions for Chronic Pain in Children

A Pilot Study of the Effectiveness of Lidocaine Infusions for the Management of Chronic Pain in Children

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 Overview

• Status: Completed
• Conditions: Pain, Chronic
• Intervention / Treatment: Drug: Lidocaine Infusion

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lisa Isaac, MD; Phone Number: 416-813-6410; Email: lisa.isaac@sickkids.ca
• Study Contact Backup: Name: Carolyne Pehora, RN; Phone Number: 202406 416-813-7654; Email: carolyne.pehora@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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")

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine Infusion; 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.	Drug: Lidocaine Infusion; Patients will receive lidocaine infusion of 42 micrograms/kg/minute over tow hours for a total of 5 mg/kg.; Other Names: Preservative Free Lidocaine Hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Lisa Isaac, MD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: April 15, 2016
• First Submitted That Met QC Criteria: December 5, 2016
• First Posted (Estimated): December 6, 2016

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Children; Pediatrics; Lidocaine; Anesthetics, Local
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 1000052256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No