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Lidocaine Infusion for Chronic Pain in Children
Study Summary
This trial will test if lidocaine can help relieve chronic pain in children and if it is safe to use.
- Chronic Pain
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 4 trial • 40 Patients • NCT01602692Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Lidocaine Infusion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
To be eligible for this test, what do potential participants need to qualify?
"This clinical trial is looking for 20 participants, aged 8-18, who have chronic pain that has not responded to other treatments. Eligible patients must also meet the following criteria: American Society of Anesthesiologists class 1 or 2, ability to understand and use the numeric rating scale to rate their pain, and negative pregnancy test for participants of child-bearing potential (females 12 years of age and older, or menarchal if under 12)."
Has the FDA cleared Lidocaine Infusion for public use?
"Lidocaine Infusion received a score of 3 on Power's safety scale. This is due to Phase 3 trial data, which provides support for both efficacy and safety."
Are there any other similar case studies to the Lidocaine Infusion?
"There are a total of 135 clinical trials studying lidocaine infusion, 34 of which are in Phase 3. Although most research is conducted in Calgary, Alberta, lidocaine infusion studies are being conducted at 1,110 locations worldwide."
Are adults the only age group being recruited for this trial?
"According to the eligibility criteria for this trial, the minimum age for enrollment is 8 and the maximum age is 18."
What are some of the conditions that Lidocaine Infusion is known to help?
"Lidocaine Infusion is commonly used to alleviate cervical syndrome, but it can also be used to help patients with minor burns, osteoporosis, and transplantation."
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