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IV Lidocaine for Post-Operative Pain in Pediatric Spinal Conditions (PEDS LIDO Trial)
PEDS LIDO Trial Summary
This trial will look at the effects of lidocaine on post-operative pain management for AIS patients. Lidocaine will be compared to a placebo to see if it can help reduce pain and the need for opioids.
PEDS LIDO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPEDS LIDO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 4 trial • 86 Patients • NCT03540030PEDS LIDO Trial Design
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Who is running the clinical trial?
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- I am able to understand and consent to the surgery or study on my own.I have had seizures in the past or have a seizure disorder.My parent or guardian can give consent for me to join the study.I am either younger than 12 or older than 18 years old.I am between 12 and 18 years old.You are already participating in another clinical trial.You are allergic to bupivacaine.I have or had an irregular heartbeat or a mild heart block.I have been diagnosed with sepsis or an infection.I have been diagnosed with cancer, either at its original site or spread to other parts.I have scoliosis and need surgery to correct my spine.My scoliosis treatment will involve surgery from the front.
- Group 1: Control Group
- Group 2: Study Group
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Am I eligible for involvement in this medical experiment?
"This clinical investigation is searching for 70 participants aged 12-18 who have lidocaine. Eligible applicants are encouraged to apply."
Is the eligibility criterion for this medical experiment restricted to those under 35 years of age?
"This clinical research is available to minors ranging in age from 12 to 18 years old."
Has intravenous lidocaine been certified by the FDA?
"Having already been approved for use, IV lidocaine earned a rating of 3 due to extensive data demonstrating its safety."
What additional research has been pursued regarding the intravenous administration of lidocaine?
"Currently, there are 118 active clinical trials looking into the efficacy of intravenous lidocaine. Of those studies, 31 have advanced to Phase 3 and can be found at 1,094 different sites with a majority in Calgary, Alberta."
Is this research endeavor still recruiting participants?
"This clinical trial is not currently accepting patients: it was first advertised on July 30th 2019 and the last reported change to its information was posted on December 7th 2021. Although this particular study has reached capacity, there are 119 alternative studies actively recruiting participants at present."
For what type of medical conditions is IV lidocaine typically prescribed?
"Intravenous lidocaine is typically administered to palliate cervical syndrome, yet it also offers therapeutic efficacy for minor burns, transplantation and osteoporosis."
What is the total number of participants recruited for this medical experiment?
"This trial is currently not open to enrollment. Initially posted on July 30th 2019 and last edited December 7th 2021, the study has been closed for recruitment. Alternatively, there are 1 studies actively recruiting patients with lidocaine, as well as 118 trials utilizing IV lidocaine that remain open at this time."
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