Overview

PK Intravenous Lidocaine Infusion

Status:
Terminated
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
Summary
To determine safe concentration level of lidocaine infusion in children.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Treatments:
Lidocaine
Criteria
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