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IV Lidocaine for Contrast-Related Pain

Phase 4
Waitlist Available
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
~1 spots leftby May 2025
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