PK Intravenous Lidocaine Infusion

Colorectal Surgery Clinical Trial

Official title:

Pharmacokinetics of Intravenous Lidocaine Infusion in Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02241096
• Other study ID #: 2014-3194
• Status: Terminated
• Phase: Phase 1
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: February 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine safe concentration level of lidocaine infusion in children.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bulloch B, Tenenbein M. Validation of 2 pain scales for use in the pediatric emergency department. Pediatrics. 2002 Sep;110(3):e33. — View Citation

Candiotti KA, Yang Z, Morris R, Yang J, Crescimone NA, Sanchez GC, Bird V, Leveillee R, Rodriguez Y, Liu H, Zhang YD, Bethea JR, Gitlin MC. Polymorphism in the interleukin-1 receptor antagonist gene is associated with serum interleukin-1 receptor antagonist concentrations and postoperative opioid consumption. Anesthesiology. 2011 May;114(5):1162-8. doi: 10.1097/ALN.0b013e318216e9cb. — View 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. — View 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. Review. — View 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. — View Citation

Kuo CP, Jao SW, Chen KM, Wong CS, Yeh CC, Sheen MJ, Wu CT. Comparison of the effects of thoracic epidural analgesia and i.v. infusion with lidocaine on cytokine response, postoperative pain and bowel function in patients undergoing colonic surgery. Br J Anaesth. 2006 Nov;97(5):640-6. Epub 2006 Sep 4. — View Citation

McGrath PA, Seifert CE, Speechley KN, Booth JC, Stitt L, Gibson MC. A new analogue scale for assessing children's pain: an initial validation study. Pain. 1996 Mar;64(3):435-43. — View Citation

Yardeni IZ, Beilin B, Mayburd E, Levinson Y, Bessler H. The effect of perioperative intravenous lidocaine on postoperative pain and immune function. Anesth Analg. 2009 Nov;109(5):1464-9. doi: 10.1213/ANE.0b013e3181bab1bd. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safe serum levels of lidocaine infusion (<5 mcg/ml of lidocaine in blood)	Blood samples will be obtained at predetermined times after start and finish of lidocaine infusion. Each sample is 1ml. Samples will be obtained at the baseline placement of IV, 0 - 3 minutes after bolus has completed, 9 - 15 minutes after bolus infusion, 4 minutes prior to end or at the end of the continuous infusion, 55 - 65 following the end of infusion, 2 - 7 hours after completion of continuous infusion and 20 - 24 hours after completion of infusion if clinical labs are also necessary.	Samples will be collected until the end of the OR case and up to 24 hours after surgery
Secondary	Safe metabolite levels (monoethylglycinexylidide (MEGX) and glycinexylidide (GX) with intraoperative IV lidocaine infusions	We will monitor monoethylglycinexylidide (MEGX) and glycinexylidide (GX).; Blood samples (1ml each) for metabolites will be as follows: baseline with initial placement, 4 minutes after infusion completed, 2 - 7 hours after infusion completion, 20 - 24 hours after infusion completion if clinical labs are being drawn	Samples will be collected until the end of the OR case and up to 24 hours after surgery