Safety of Intravenous Lidocaine Infusions
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Purpose
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.
| Condition |
|---|
|
Neuropathic Pain |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Safety of Intravenous Lidocaine Infusions for Chronic Neuropathic Pain |
| Enrollment: | 70 |
| Study Start Date: | June 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Lidocaine
Adults >18 yrs , attending St Joseph's Health Care Pain Clinic with a diagnosis of chronic neuropathic pain who are being treated with an lidocaine infusion of 5 mg/kg over 45 minutes Consecutive patients from two time periods:
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adult outpatients attending St Joseph's Chronic Pain Clinic in one of two time periods who have been diagnosed with chronic neuropathic pain by clinical history and examination and are scheduled to receive a lidocaine infusion for pain management
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
Contacts and Locations| Canada, Ontario | |
| St Joseph's Health Care | |
| London, Ontario, Canada, N6A 4V2 | |
| Principal Investigator: | Patricia K Morley-Forster, MD, FRCPC | Associate Professor,Dept of Anesthesia and Perioperative Medicine,University of Western Ontario, Lawson Health Research Institute |
| Principal Investigator: | Patricia K Morley-Forster, MD, FRCPC | Associate Professor, University of Western Ontario, Lawson Health Research Institute |
More Information
Publications:
| Responsible Party: | Patricia Morley-Forster, St Joseph's Health Care |
| ClinicalTrials.gov Identifier: | NCT01091935 History of Changes |
| Other Study ID Numbers: | R-08-341, 15240E |
| Study First Received: | March 22, 2010 |
| Last Updated: | March 23, 2010 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Lawson Health Research Institute:
|
Lidocaine,Intravenous Infusions,Neuropathic Pain,Side Effects |
Additional relevant MeSH terms:
|
Neuralgia Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Lidocaine Anesthetics, Local Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013