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IV Lidocaine for Contrast-Related Pain

Phase 4
Recruiting
Led By Christine Rizkalla, MD
Research Sponsored by Antonios Likourezos
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Require CT scan with IV contrast
Patients with age of 7 to 17 years-old who require a CT scan with IV contrast
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes
Awards & highlights

Study Summary

This trial is testing whether pre-treatment with lidocaine can help mitigate the immediate discomfort of IV contrast in children and adolescents who can comply with a pre and post IV contrast pain assessment.

Who is the study for?
This trial is for children and teens aged 7 to 17 who need a CT scan with IV contrast. It's not for those with heart disease, neurodevelopmental conditions affecting pain assessment, seizure history, trauma patients, or anyone allergic to lidocaine.Check my eligibility
What is being tested?
The study tests if pretreatment with Lidocaine can reduce the discomfort of IV contrast during CT scans in kids. Participants will be randomly given either Lidocaine or a saline solution without knowing which one they received.See study design
What are the potential side effects?
Lidocaine is generally safe but could potentially cause mild reactions like redness or pain at the injection site. Serious side effects are rare but may include seizures or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I need a CT scan with IV contrast.
Select...
I am between 7 and 17 years old and need a CT scan with IV contrast.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain score at 15 minutes post medication administration
Pain score at 30 minutes post medication administration
Secondary outcome measures
Pain score at 120 minutes post medication administration
Pain score at 60 minutes post medication administration
Pain score at 90 minutes post medication administration

Trial Design

2Treatment groups
Active Control
Group I: Preservative Free Lidocaine GroupActive Control1 Intervention
The patient will receive a 1mg/kg IV dose of preservative free lidocaine with a max dose of 40mg
Group II: Placebo GroupActive Control1 Intervention
The patient will receive IV normal saline of 1mg/kg with a max of 40mg

Find a Location

Who is running the clinical trial?

Antonios LikourezosLead Sponsor
38 Previous Clinical Trials
8,498 Total Patients Enrolled
17 Trials studying Pain
1,345 Patients Enrolled for Pain
Christine Rizkalla, MDPrincipal InvestigatorMaimonides Medical Center

Media Library

Preservative Free Lidocaine Group Clinical Trial Eligibility Overview. Trial Name: NCT05143489 — Phase 4
Pain Research Study Groups: Preservative Free Lidocaine Group, Placebo Group
Pain Clinical Trial 2023: Preservative Free Lidocaine Group Highlights & Side Effects. Trial Name: NCT05143489 — Phase 4
Preservative Free Lidocaine Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05143489 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Preservative Free Lidocaine Group typically utilized to treat?

"Preservative Free Lidocaine Group is a recommended treatment for cervical syndrome, as well as minor burns, transplantation and osteoporosis."

Answered by AI

What are the criteria for inclusion in this clinical study?

"The prerequisites for the trial is that patients must be between 7 -17 and have pain. Around eighty people are being considered to participate in this experiment."

Answered by AI

Have any other trials been conducted involving Preservative Free Lidocaine Group?

"Currently, 118 studies are ongoing for Preservative Free Lidocaine Group with 31 of them in the third phase. Most tests are located in Calgary, Alberta; however there exist 1094 locations conducting such clinical trials."

Answered by AI

Is the process of participant enrollment still open?

"According to clinicaltrials.gov, the search for participants is still ongoing. The trial was first announced on March 1st 2022 and recently updated on January 18th 2022."

Answered by AI

Is the sample population of this research study inclusive of seniors?

"Candidates for this research project must be between 7 and 17 years old. Of the 429 total trials, 81 target minors while 348 focus on elderly individuals."

Answered by AI

How many individuals are being accepted into the research program?

"Affirmative. Clinicaltrials.gov confirms that on 1/3/2022 this research project was posted and has since been updated, showing it is presently recruiting candidates. So far 80 patients have signed up at one medical site."

Answered by AI

Does Preservative Free Lidocaine Group present any hazards to individuals?

"Accounting for the status of Phase 4 clinical trials, our team at Power gave Preservative Free Lidocaine Group a safety rating of 3. As such, it qualifies as an approved treatment modality."

Answered by AI
~10 spots leftby Aug 2024