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NCT01091935 Clinical Trial

Safety of Intravenous Lidocaine Infusions

Neuropathic Pain Clinical Trial

Official title:
Safety of Intravenous Lidocaine Infusions for Chronic Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01091935
Other study ID # R-08-341
Secondary ID 15240E
Status Completed
Phase N/A
First received March 22, 2010
Last updated March 23, 2010
Start date June 2009
Est. completion date January 2010

Study information
Verified date March 2010
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to prospectively determine the side effects profile in adults with neuropathic pain receiving intravenous infusions of lidocaine 5 mg per kg of lean body weight, infused over 45 minutes.

Description:

Eligibility Criteria:

Adults > 18 yrs with chronic central or peripheral neuropathic pain at the St Joseph's Health Care Pain Clinic between June and December 2009.

Outcome measures: All side effects spontaneously reported. Sedation, nausea, dizziness by Visual Analog Score Q 15 minutes; hemodynamic data q 5 minutes during and after infusion for 30 minutes.

Daily diary of side effects and Visual Analogue score of Pain for 7 days post-infusion.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Adult outpatients > 18 years < 80 years diagnosed with chronic neuropathic pain

Exclusion Criteria:

- Unable to provide informed consent

- Unable to speak and understand English

- Liver, kidney, or cardiac failure

- Allergy to Lidocaine

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada St Joseph's Health Care London Ontario

Sponsors (2)
Lead Sponsor Collaborator
Lawson Health Research Institute University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Attal N, Gaudé V, Brasseur L, Dupuy M, Guirimand F, Parker F, Bouhassira D. Intravenous lidocaine in central pain: a double-blind, placebo-controlled, psychophysical study. Neurology. 2000 Feb 8;54(3):564-74. — View Citation

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