drugset / Trial / NCT05143489

The Effect of Pretreatment With Intravenous Lidocaine for Intravenous Contrast:

NCT05143489 ↗

Phase 4 Terminated 3 enrolled Antonios Likourezos
RandomizedParallel-groupQuadruple-blindTreatment

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 post IV contrast pain assessment.

Timeline

Start
2022-01-03
Primary completion
2024-04-17
Completion
2024-04-17

Outcome

Outcome not reported

Stopped: “1\. CTs occur late at night and weekends when their is no availability of the research staff. . No activity since a year+”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lidocaine Other / unclassified 1 mg/kg Intravenous

Indications

No indication recorded.