NCT02983682

Lidocaine Infusions for Chronic Pain in Children

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Chronic

Interventions

Type	Name	Description
DRUG	Lidocaine Infusion	Patients will receive lidocaine infusion of 42 micrograms/kg/minute over tow hours for a total of 5 mg/kg.

Timeline

• Start date: 2017-01-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2016-12-06
• Last updated: 2024-01-19

Locations

1 site across 1 country: Canada