PK Intravenous Lidocaine Infusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

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To determine safe concentration level of lidocaine infusion in children.

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Detailed Description

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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.

Conditions

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Colorectal Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Lidocaine

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

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

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

Interventions

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Lidocaine

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

Intervention Type DRUG

Other Intervention Names

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xylocaine

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No