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NCT05143489 · ClinicalTrials.gov registry record · Phase 4
The Effect of Pretreatment With Intravenous Lidocaine for Intravenous Contrast:
A Phase 4 study, sponsored by Antonios Likourezos.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT05143489 is a Phase 4 study that was terminated before completion, run by Antonios Likourezos. The registered enrollment target is 3 participants.
The verdict
NCT05143489, a Phase 4 study, was terminated before completion, sponsored by Antonios Likourezos.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
Intravenous contrast media is commonly used for CT scans for improved image clarity in pediatric emergency medicine. Children who feel discomfort during the administration of IV contrast media may not remain still during the CT scan, which affects the overall study quality and reliability. Therefore, many young patients often undergo procedural sedation in anticipation of movement artifact degrading the diagnostic accuracy. Procedural sedation, while a common procedure in the pediatric emergency department, does have significant complications, and it increases the risk of adverse events for the patient. The risk of airway compromise associated with procedural sedation is particularly concerning in children requiring IV contrast for imaging of an upper airway pathology such as retropharyngeal abscess, as the disease itself narrows the airway. This presents the physician with a dilemma of assessing the extent of the disease without the additional risk of airway compromise by using procedural sedation.Previous research has looked at premedication with steroids prior to IV-contrast media administration to avert an allergic response. However, there has been no investigation of premedication to abate the immediate adverse effects of discomfort associated with IV contrast injection. The safety of IV lidocaine in pediatric patients has been documented in studies of its use for post-operative pain, using doses from 1.0 to 1.5 mg/kg with no known adverse side effects. CT scans with IV contrast are performed on a near-daily basis in the Maimonides pediatric emergency department, usually for the assessment of acute appendicitis. The standard of care in children and adults receiving IV contrast does not include pre-medication to prevent IV contrast-associated discomfort. This double-blinded prospective study aims to determine whether pre-treatment with lidocaine can mitigate the immediate discomfort of IV contrast in verbal children and adolescents who can comply with a pre and
Interventions
- DRUG Saline
- DRUG Preservative Free Lidocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-01-03 |
| Est. Completion | 2024-04-17 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05143489
The ClinicalTrials.gov registry entry for NCT05143489 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Antonios Likourezos, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT05143489 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05143489 about?
NCT05143489 is a clinical study titled "The Effect of Pretreatment With Intravenous Lidocaine for Intravenous Contrast:". Intravenous contrast media is commonly used for CT scans for improved image clarity in pediatric emergency medicine. Children who feel discomfort during the administration of IV contrast media may not remain still during the CT scan, which affects the overall study quality and reliability. Therefore...
What is the current status of trial NCT05143489?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2022-01-03. Estimated completion is 2024-04-17.
What interventions are being tested in trial NCT05143489?
The interventions under investigation include: Saline (DRUG), Preservative Free Lidocaine (DRUG).
Who is sponsoring clinical trial NCT05143489?
This trial is sponsored by Antonios Likourezos, which has 33 total clinical trials registered on ClinicalTrials.gov.
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