PK Intravenous Lidocaine Infusion

Stopped early · Phase 1

Conditions studied: Colorectal Surgery

In brief

To determine safe concentration level of lidocaine infusion in children.

Key facts

Study ID

NCT02241096

Run by

Children's Hospital Medical Center, Cincinnati

People needed

2

Starts

2015-01-01

Expected to finish

2015-09-01

Last updated by the study team

2020-03-02

Who can join

Age: 3 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• male or female children 3-15 years of age
• ASA physical status 1-3
• scheduled for colorectal surgery with abdominal incision

You may not qualify if…

• 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

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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