Lidocaine Infusions for Chronic Pain in Children

NCT02983682 | Completed Phase 3

• 1 other identifier: 1000052256
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic

Keywords

Anesthetics, Local; Lidocaine; Pediatrics; Children; Adolescents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Analgesic Requirement

  Up to seven days prior to lidocaine infusion.

• Analgesic Requirement

  Up to one month after lidocaine infusion

• Adverse Events

  intraoperative

Other Outcomes (3)

• Sleep

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

• Pain Interference

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

• School Attendance

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

Study Arms (1)

Lidocaine Infusion

EXPERIMENTAL

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

Interventions

Lidocaine Infusion DRUG

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

Also known as: Preservative Free Lidocaine Hydrochloride

Lidocaine Infusion

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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")

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Isaac, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: December 6, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)