Status:
TERMINATED
PK Intravenous Lidocaine Infusion
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Colorectal Surgery
Eligibility:
All Genders
3-15 years
Phase:
PHASE1
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 wi...
Eligibility Criteria
Inclusion
- male or female children 3-15 years of age
- ASA physical status 1-3
- scheduled for colorectal surgery with abdominal incision
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT02241096
Start Date
January 1 2015
End Date
September 1 2015
Last Update
March 2 2020
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229