PK Intravenous Lidocaine Infusion

February 27, 2020 updated by: Children's Hospital Medical Center, Cincinnati

Pharmacokinetics of Intravenous Lidocaine Infusion in Children

To determine safe concentration level of lidocaine infusion in children.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study will address the working hypothesis that intravenous lidocaine may be administered as a bolus followed by an infusion with reliable and safe blood levels of lidocaine. Serial blood draws will be obtained to determine safety of lidocaine doses used in this study by measuring blood levels of lidocaine and its metabolites.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female children 3-15 years of age
  • ASA physical status 1-3
  • scheduled for colorectal surgery with abdominal incision

Exclusion Criteria:

  • ASA physical status > 3
  • postoperative intubation planned ahead of surgery
  • history of chronic use of opioid (use longer than 3 months)
  • history of hepatic, renal, or cardiac failure
  • history of significant liver disease including liver failure, acute or chronic hepatitis, hepatomegaly, portal hypertension and elevated liver enzymes
  • history of organ transplant
  • BMI > 30
  • history of cardiac arrhythmia
  • history of long QT syndrome
  • history of allergic reaction to lidocaine or similar agents
  • history of seizure disorder
  • patient without PICC or other central access with contraindication to inhalation induction
  • family history or known patient susceptibility to malignant hyperthermia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidocaine
IV lidocaine bolus of 1.5mg/kg over 10 minutes followed by a 1mg/kg/hr IV lidocaine infusion.
Drug: Lidocaine
IV lidocaine bolus of 1.5mg/kg over 10 minutes followed by a 1mg/kg/hr IV lidocaine infusion.
Other Names:
  • xylocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safe serum levels of lidocaine infusion (<5 mcg/ml of lidocaine in blood)
Time Frame: Samples will be collected until the end of the OR case and up to 24 hours after surgery
Blood samples will be obtained at predetermined times after start and finish of lidocaine infusion. Each sample is 1ml. Samples will be obtained at the baseline placement of IV, 0 - 3 minutes after bolus has completed, 9 - 15 minutes after bolus infusion, 4 minutes prior to end or at the end of the continuous infusion, 55 - 65 following the end of infusion, 2 - 7 hours after completion of continuous infusion and 20 - 24 hours after completion of infusion if clinical labs are also necessary.
Samples will be collected until the end of the OR case and up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safe metabolite levels (monoethylglycinexylidide (MEGX) and glycinexylidide (GX) with intraoperative IV lidocaine infusions
Time Frame: Samples will be collected until the end of the OR case and up to 24 hours after surgery

We will monitor monoethylglycinexylidide (MEGX) and glycinexylidide (GX).

Blood samples (1ml each) for metabolites will be as follows: baseline with initial placement, 4 minutes after infusion completed, 2 - 7 hours after infusion completion, 20 - 24 hours after infusion completion if clinical labs are being drawn
Samples will be collected until the end of the OR case and up to 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Smokey J Clay, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-3194

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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