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Lidocaine Infusions for Chronic Pain in Children

Primary Purpose

Pain, Chronic

Status

Recruiting

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Lidocaine Infusion

About this trial

This is an interventional treatment trial for Pain, Chronic focused on measuring Anesthetics, Local, Lidocaine, Pediatrics, Children, Adolescents

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosed with a chronic pain condition (> 3 months) other conventional medical therapies (anticonvulsants, tricyclics etc), have not been effective.
American Society of Anesthesiologists class 1 or 2
Age 8-18 years
Ability to understand and use the numeric rating scale to rate their pain and to understand and answer other questionnaires
Negative pregnancy test in participants of child-bearing potential (Females 12 years of age and older, or menarchal if under 12)

Exclusion Criteria:

History of seizures
Known liver or renal disease
Patient taking strong CYP1A2 inducers or inhibitors (fluvoxamine, phenytoin, cimetidine, amiodarone) or beta blockers (propranolol, metoprolol, nadolol)
Allergy or sensitivity to lidocaine or other local anesthetic
Cardiac conduction anomalies (eg. Heart block, Wolff-Parkinson-White)
Serum electrolytes (potassium, sodium, magnesium or calcium) outside of reference ranges
Pregnancy

Withdrawal Criteria

Patient or parent/guardian request
Refusal to have intravenous access and serum levels drawn
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
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")

Sites / Locations

The Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lidocaine Infusion

Arm Description

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.

Outcomes

Primary Outcome Measures

Pain Score

Pain scores will be measured using the Numeric Rating Scale

Secondary Outcome Measures

Analgesic Requirement

Participants will record all analgesics used in a pain diary provided by the investigators.

Analgesic Requirement

Participants will record all analgesics used in a pain diary provided by the investigators.

Adverse Events

Participants will be monitored for adverse events including cardiac arrhythmias, hypotension, hypertension, tachycardia, metallic taste, tinnitus, lightheadedness, nausea, vomiting and headache

Full Information

NCT ID

NCT02983682

First Posted

April 15, 2016

Last Updated

June 21, 2022

Sponsor

The Hospital for Sick Children

1. Study Identification

Unique Protocol Identification Number

NCT02983682

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 2017 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Chronic

Keywords

Anesthetics, Local, Lidocaine, Pediatrics, Children, Adolescents

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine Infusion

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Lidocaine Infusion

Other Intervention Name(s)

Preservative Free Lidocaine Hydrochloride

Intervention Description

Patients will receive lidocaine infusion of 42 micrograms/kg/minute over tow hours for a total of 5 mg/kg.

Primary Outcome Measure Information:

Title

Pain Score

Description

Pain scores will be measured using the Numeric Rating Scale

Time Frame

Change from baseline pain score (7 days prior to infusion) at 14 days after completion of infusion

Secondary Outcome Measure Information:

Title

Analgesic Requirement

Description

Participants will record all analgesics used in a pain diary provided by the investigators.

Time Frame

Up to seven days prior to lidocaine infusion.

Title

Analgesic Requirement

Description

Participants will record all analgesics used in a pain diary provided by the investigators.

Time Frame

Up to one month after lidocaine infusion

Title

Adverse Events

Description

Participants will be monitored for adverse events including cardiac arrhythmias, hypotension, hypertension, tachycardia, metallic taste, tinnitus, lightheadedness, nausea, vomiting and headache

Time Frame

intraoperative

Other Pre-specified Outcome Measures:

Title

Sleep

Description

The Adolescent Sleep Wake Scale will be used to assess quantity and quality of sleep.

Time Frame

Day of the infusion, one week, two weeks and four weeks following the infusion.

Title

Pain Interference

Description

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

Time Frame

Day of the infusion, one week, two weeks and four weeks following infusion.

Title

School Attendance

Description

Participants will record the number of hours of school attendance where relevant (e.g. no school holidays, no medical appointments).

Time Frame

Week prior to the infusion and at two and four weeks following the infusion.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosed with a chronic pain condition (> 3 months) other conventional medical therapies (anticonvulsants, tricyclics etc), have not been effective. American Society of Anesthesiologists class 1 or 2 Age 8-18 years Ability to understand and use the numeric rating scale to rate their pain and to understand and answer other questionnaires Negative pregnancy test in participants of child-bearing potential (Females 12 years of age and older, or menarchal if under 12) Exclusion Criteria: History of seizures Known liver or renal disease Patient taking strong CYP1A2 inducers or inhibitors (fluvoxamine, phenytoin, cimetidine, amiodarone) or beta blockers (propranolol, metoprolol, nadolol) Allergy or sensitivity to lidocaine or other local anesthetic Cardiac conduction anomalies (eg. Heart block, Wolff-Parkinson-White) Serum electrolytes (potassium, sodium, magnesium or calcium) outside of reference ranges Pregnancy Withdrawal Criteria Patient or parent/guardian request Refusal to have intravenous access and serum levels drawn 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 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")

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lisa Isaac, MD

Phone

416-813-6410

lisa.isaac@sickkids.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Carolyne Pehora, RN

Phone

416-813-7654

Ext

202406

carolyne.pehora@sickkids.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa Isaac, MD

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lisa Isaac, MD

Phone

416-813-6410

lisa.isaac@sickkids.ca

First Name & Middle Initial & Last Name & Degree

Carolyne Pehora, RN

Phone

416-813-7654

Ext

202406

carolyne.pehora@sickkids.ca

12. IPD Sharing Statement

Plan to Share IPD

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