CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 162 enrolled
Drug / intervention
Lidocaine Hydrochloride 2% Intravenous Solution, DIN 02421992drug
Likely dose
Lidocaine Hydrochloride 2% Intravenous Solution, DIN 02421992 5.0 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04123652
NCT04123652Phase 4Completed

Ambulatory Infusions of Lidocaine and Ketamine for Management of Chronic Pain: an Observational Prospective Study

Allevio Pain Management Clinic·interventional·Posted Oct 11, 2019·Updated Dec 4, 2020

In Brief

A Phase 4 clinical trial evaluating Lidocaine Hydrochloride 2% Intravenous Solution, DIN 02421992 for Chronic Neuropathic Pain and Fibromyalgia. Completed, enrolled 162 participants across 1 site.

Detailed Summary

As lidocaine and ketamine provide analgesia by acting on different molecular pathways, administering them together may produce synergistic effects, which can allow for using a lower dose of each medication and thereby reducing the corresponding side effects. To the investigator's knowledge, despite the common practice of multimodal analgesia, lidocaine-ketamine infusions have never been studied prospectively in an out of hospital setting to treat neuropathic pain. The aim of the present study is to evaluate the effectiveness of the current routine practice of lidocaine-ketamine infusions conducted at Allevio Pain Management Clinic, a large outpatient community based chronic pain management facility. Lidocaine-ketamine infusions are prescribed to patients that have pain that is considered to be neuropathic for which standard anti-neuropathic medications have been ineffective or poorly tolerated by patients. A prospective longitudinal study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedOct 11, 2019
Enrollment StartNov 5, 2017
Primary CompletionNov 11, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.7 years ago

Interventions

Lidocaine Hydrochloride 2% Intravenous Solution, DIN 02421992drug

An intravenous will be started. • Lidocaine - initial dose of 5.0 mg/kg +/- 1.0 mg/kg (based on actual weight, up to maximum dose 600 mg) over 45 minutes, followed by increases of 0.5 mg/kg each infusion based on tolerability of side effects, not to exceed 7 mg/kg or 600 mg. • Ketamine - initial dose of 0.1 mg/kg (based on actual weight) over 45 minutes (rounded to nearest 5 mg, up to maximum 15 mg), increased by 0.1 mg/kg (rounded to nearest 5 mg) each infusion based on tolerability of side effects During the infusion patient will be monitored by another MD for BP, PR, PO2. Patients will not be allowed to drive for 24 hours.