CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Instilled 1% Lidocaine +1 moredrug
Likely dose
Instilled 1% Lidocaine 5 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/NCT00585325
NCT00585325N/ACompleted

Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes.

University of Wisconsin, Madison·interventional·Posted Jan 3, 2008·Updated Mar 7, 2018

In Brief

A clinical study evaluating Instilled 1% Lidocaine and Placebo (0.9% Normal Saline) for Burn. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Patients will be randomized prospectively to one of two groups. One group will receive 5 mg/kg of 1% lidocaine, and the other will receive .9 normal saline, instilled into their VAC sponge ½ hour prior to VAC dressing change. All patients will complete a pain assessment tool prior to receiving the instilled lidocaine/placebo, immediately after the procedure and 1 hour after the procedure. Pain scores will then be compared between the lidocaine and placebo groups. Risks: Lidocaine toxicity is a potential risk, but 5 mg/kg of 1 % Lidocaine is below toxicity thresholds in an adult.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBurn
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 3, 2008
Enrollment StartOct 1, 2004
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 18.5 years ago

Interventions

Instilled 1% Lidocainedrug

5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change

Placebo (0.9% Normal Saline)other

.9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change