PK Intravenous Lidocaine Infusion

Cincinnati Children's Hospital Medical Center

Status and phase: Terminated; Phase 1

Conditions: Colorectal Surgery

Treatments: Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02241096

2014-3194

Details and patient eligibility

About

To determine safe concentration level of lidocaine infusion in children.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Lidocaine

Experimental group

Description:

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

Treatment:

Drug: Lidocaine