Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05143489 |
| Other study ID # |
2021-01-14 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
January 3, 2022 |
| Est. completion date |
April 17, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Maimonides Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
STUDY DESIGN Subjects: Patients aged from 7 to 17 years-old who present to the Maimonides
Medical Center's Emergency Department that require a CT scan with IV contrast. Research team
members will be notified when the patient requires CT scan with IV contrast and meets the
eligibility criteria. Potential subjects will be recruited in the Emergency Department
Eligibility Criteria: Inclusion criteria: Patients with age of 7 to 17 years-old who require
a CT scan with IV contrast. Exclusion criteria: Patients with history of seizures,
cardiovascular disease, presenting as a trauma, a history of anaphylaxis to lidocaine, or
children/adolescents with underlying neurodevelopmental conditions which would interfere with
their ability to respond to pre and post IV contrast pain assessments.
Design: This is a prospective, double-blinded randomized control study that will be comparing
intravenous lidocaine to a placebo. Patients will be randomized with block randomization. The
randomization list will be generated EM Research Manager and given to the EM pharmacist a
priori of commencement of the study. The EM Research Manager and EM Pharmacist are not
blinded to the study. Once a potential subject has been identified, a member of the research
team will obtain consent from the parent or guardian of the subject. The research team member
involved with consent and data collection, provider, and subject will all be blinded to which
treatment arm they are assigned.
The research team members will monitor each patient and in conjunction with the pharmacy will
deliver the assigned treatment to the subject's nurse to administer 10 min prior to the CT
scan. If selected for the treatment group, the patient will receive a 1mg/kg IV dose of
lidocaine with a max dose of 40mg.15 A patient selected to the control group will an equal
volume of normal saline infused. A research team member will be present during the
administration of assigned treatment until the completion of the CT scan. The patient will be
placed on a cardiopulmonary monitor for the duration of this period. Advanced airway
equipment, IV midazolam, and IV intralipids will also be available at bedside during infusion
and until completion of CT scan to treat any potential adverse effect associated with
lidocaine.
Nominal variables to be collected include gender, chief complaint, pain score at triage, use
of pain medication at triage and during the ED course, diagnosis, type of CT scan performed,
pre and post-intervention pain score, post-intervention pruritus score, post-intervention
burning pain score. The only continuous variable being collected includes age (in years-old).
There will be no interruption or deviation from the standard of clinical care provided to
each subject. This study will be run completely in the Pediatric Emergency Department.
Data Collection Procedures: Once a subject has been enrolled, the research team member will
review the chart and collect all pertinent information as shown in the data collection
template. A questionnaire will be completed prior to administration of the medication as well
as following the CT scan which will be administered by the research team member. The
investigators 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. Once all data has been
collected, it will be recorded in password protected document located on a secure server only
accessible to members of the research team. All information about the patients will be
de-identified. Study investigators will record pain scores, vital signs, and adverse effects
at prior to intervention, immediately following intervention, and 15 min following the
intervention
The preparing ED pharmacist, research manager, and statistician will be the only ones with
knowledge of the study arm to which each participant would be randomized. Treating providers,
participants, and the data collecting research team will be blind to the medication route
received.
All data will be recorded on data collection sheets, including patients' gender,
demographics, medical history, and vital signs, and entered into SPSS (version 27.0; IBM
Corp) by the research manager. Development of the randomization list, confirmation of written
consent acquisition for all participants, and statistical analyses will be conducted by the
research manager and statistician who will work independently of any data collection.
Patients will be closely monitored for any change in vital sings and for adverse effects
during the entire study period (up to 120 minutes) by study investigators.
