The Effect of Pretreatment With Intravenous Lidocaine for Intravenous Contrast:

NCT05143489 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 2021-01-14
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

Pain; Pediatrics; Emergency Medicine; Lidocaine

Outcome Measures

Primary Outcomes (2)

• Pain Score at 15 Minutes Post Medication Administration

  We will use a combination of the Baker-Wong FACES pain scale and 1 to 10 numerical scale for pain as well as a 5-point Likert scale for discomfort. Both scales range from no pain to very severe pain with 5 being moderate pain.

  15 minutes

• Pain Score at 30 Minutes Post Medication Administration

  We will use a combination of the Baker-Wong FACES pain scale and 1 to 10 numerical scale for pain as well as a 5-point Likert scale for discomfort. Both scales range from no pain to very severe pain with 5 being moderate pain.

  30 minutes

Secondary Outcomes (3)

• Pain Score at 60 Minutes Post Medication Administration

  60 minutes

• Pain Score at 90 Minutes Post Medication Administration

  90 minutes

• Pain Score at 120 Minutes Post Medication Administration

  120 minutes

Study Arms (2)

Preservative Free Lidocaine Group

ACTIVE COMPARATOR

The patient will receive a 1mg/kg IV dose of preservative free lidocaine with a max dose of 40mg

Drug: Preservative Free Lidocaine

Placebo Group

ACTIVE COMPARATOR

The patient will receive IV normal saline of 1mg/kg with a max of 40mg

Drug: Saline

Interventions

Preservative Free Lidocaine DRUG

The patient will receive a 1mg/kg IV dose of lidocaine with a max dose of 40mg.

Preservative Free Lidocaine Group

Saline DRUG

The patient will receive IV normal saline of 1mg/kg with a max of 40mg

Placebo Group

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with age of 7 to 17 years-old who require a CT scan with IV contrast
• Require CT scan with IV contrast

You may not qualify if:

• History of seizures
• Cardiovascular disease
• Presenting as a trauma
• a history of anaphylaxis to lidocaine
• children/adolescents with underlying neurodevelopmental conditions which would interfere with their ability to respond to pre and post IV contrast pain assessments.

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Director of Research Administraton
• Organization: Maimonides Medical Center

alikourezos@maimo.org

7182836896

Study Officials

• Christine Rizkalla, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Administration Director

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 3, 2021
• Study Start: January 3, 2022
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: May 18, 2025
• Results First Posted: May 18, 2025

Record last verified: 2025-05

Locations

US (1)