PK Intravenous Lidocaine Infusion

Phase 1

Terminated

• Conditions: Colorectal Surgery
• Interventions: Drug: Lidocaine

• Registration Number: NCT02241096
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

To determine safe concentration level of lidocaine infusion in children.

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 Timeline

• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-16
• Study Start: 2015-01
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safe serum levels of lidocaine infusion (<5 mcg/ml of lidocaine in blood)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States