N/A
Completed N=23
Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes
Source: ClinicalTrials.gov NCT00585325 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Pain During Dressing Change — 6.36; 6.94 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain During Dressing Change |
6.36; 6.94 | — |
Eligibility Criteria
Inclusion Criteria
- all burn service patients with a wound vac
Exclusion Criteria
- allergy to lidocaine
Data sourced from ClinicalTrials.gov (NCT00585325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.