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Local Anesthetic
Lidocaine Infusion for Chronic Pain in Children
Phase 3
Waitlist Available
Led By Lisa Isaac, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline pain score (7 days prior to infusion) at 14 days after completion of infusion
Awards & highlights
Summary
This trial tests if lidocaine given through an IV can reduce long-term pain in children who haven't been helped by other treatments. Researchers will measure pain levels and daily activities to see if it works and is safe. Intravenous lidocaine has been studied for its pain-relieving effects in various conditions, including chronic pain and post-operative pain.
Eligible Conditions
- Chronic Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week prior to the infusion and at two and four weeks following the infusion.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week prior to the infusion and at two and four weeks following the infusion.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain Score
Secondary study objectives
Adverse Events
Analgesic Requirement
Other study objectives
Pain Interference
School Attendance
Sleep
Side effects data
From 2014 Phase 4 trial • 40 Patients • NCT0160269240%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lidocaine InfusionExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine Infusion
2010
Completed Phase 4
~410
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Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
704 Previous Clinical Trials
6,956,858 Total Patients Enrolled
8 Trials studying Chronic Pain
1,028 Patients Enrolled for Chronic Pain
Lisa Isaac, MDPrincipal InvestigatorThe Hospital for Sick Children
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are between 8 and 18 years old.You have had seizures in the past.You have a diagnosed liver or kidney disease.You are allergic to lidocaine or other numbing medicines.You are currently taking certain medications that can interact with the study drug.You have been diagnosed with a long-lasting pain condition, and other common treatments have not worked for you.Your blood test shows levels of potassium, sodium, magnesium, or calcium that are too high or too low.You have certain heart rhythm problems like heart block or Wolff-Parkinson-White syndrome.If you are a female 12 years or older (or have started having periods before 12), you need to have a negative pregnancy test.You are in good health according to the American Society of Anesthesiologists classification.
Research Study Groups:
This trial has the following groups:- Group 1: Lidocaine Infusion
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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