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Lidocaine Infusion for Chronic Pain

The Hospital for Sick Children, Toronto, Canada
Chronic PainLidocaine Infusion - Drug
Eligibility
8 - 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if lidocaine can help relieve chronic pain in children and if it is safe to use.

Eligible Conditions
  • Chronic Pain

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

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Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Change from baseline pain score (7 days prior to infusion) at 14 days after completion of infusion

Day 14
Pain Score
Day of the infusion, one week, two weeks and four weeks following infusion.
Pain Interference
Day of the infusion, one week, two weeks and four weeks following the infusion.
Sleep
Up to one month after lidocaine infusion
Analgesic Requirement
Week prior to the infusion and at two and four weeks following the infusion.
School Attendance
intraoperative
Adverse Events

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Lidocaine Cream 5%
2
10XB-101 Solution for Injection
2
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Side Effects for

Tumescent Solution With Dilute Epinephrine
40%Nausea
10%Vomiting
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01602692) in the Tumescent Solution With Dilute Epinephrine ARM group. Side effects include: Nausea with 40%, Vomiting with 10%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1 Treatment Group

Lidocaine Infusion
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Lidocaine Infusion · No Placebo Group · Phase 3

Lidocaine Infusion
Drug
Experimental Group · 1 Intervention: Lidocaine Infusion · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline pain score (7 days prior to infusion) at 14 days after completion of infusion

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
648 Previous Clinical Trials
6,920,967 Total Patients Enrolled
6 Trials studying Chronic Pain
935 Patients Enrolled for Chronic Pain
Lisa Isaac, MDPrincipal InvestigatorThe Hospital for Sick Children

Eligibility Criteria

Age 8 - 18 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You or your parent/guardian have requested not to participate.
You have been experiencing chronic pain for more than three months and have tried other treatments, such as anticonvulsants or tricyclics, but they haven't worked.
References

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](https://www.withpower.com/clinical-trials/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)." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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