Lidocaine Infusions for Chronic Pain in Children

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983682
• Other study ID #: 1000052256
• Status: Completed
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: December 2023

Study information

• Verified date: January 2024
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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")

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

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

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Primary	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	Analgesic Requirement	Participants will record all analgesics used in a pain diary provided by the investigators.	Up to seven days prior to lidocaine infusion.
Secondary	Analgesic Requirement	Participants will record all analgesics used in a pain diary provided by the investigators.	Up to one month after lidocaine infusion
Secondary	Adverse Events	Participants will be monitored for adverse events including cardiac arrhythmias, hypotension, hypertension, tachycardia, metallic taste, tinnitus, lightheadedness, nausea, vomiting and headache	intraoperative