PK Intravenous Lidocaine Infusion

Phase 1TerminatedNCT02241096

Children's Hospital Medical Center, Cincinnati2 enrolled

Overview

To determine safe concentration level of lidocaine infusion in children.

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Colorectal Surgery

Interventions

LidocaineDRUG

IV lidocaine bolus of 1.5mg/kg over 10 minutes followed by a 1mg/kg/hr IV lidocaine infusion.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Safe serum levels of lidocaine infusion (<5 mcg/ml of lidocaine in blood)

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.

Time frame: Samples will be collected until the end of the OR case and up to 24 hours after surgery

Secondary Outcomes

Safe metabolite levels (monoethylglycinexylidide (MEGX) and glycinexylidide (GX) with intraoperative IV lidocaine infusions

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

Time frame: Samples will be collected until the end of the OR case and up to 24 hours after surgery

Data from ClinicalTrials.gov

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