Clinical trial NCT02241096: PK Intravenous Lidocaine Infusion
Official title: Pharmacokinetics of Intravenous Lidocaine Infusion in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Colorectal Surgery
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 2
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 will be obtained to determine safety of lidocaine doses used in this study by measuring blood levels of lidocaine and its metabolites.

Eligibility 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

Primary outcomes:
measure: Safe serum levels of lidocaine infusion (<5 mcg/ml of lidocaine in blood)
timeFrame: Samples will be collected until the end of the OR case and up to 24 hours after surgery
Secondary outcomes:
measure: Safe metabolite levels (monoethylglycinexylidide (MEGX) and glycinexylidide (GX) with intraoperative IV lidocaine infusions
timeFrame: Samples will be collected until the end of the OR case and up to 24 hours after surgery
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Smokey J Clay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
citation: Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
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citation: Harvey KP, Adair JD, Isho M, Robinson R. Can intravenous lidocaine decrease postsurgical ileus and shorten hospital stay in elective bowel surgery? A pilot study and literature review. Am J Surg. 2009 Aug;198(2):231-6. doi: 10.1016/j.amjsurg.2008.10.015. Epub 2009 Mar 12.
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