drugset
drugset / Trial / NCT02229578

Lidocaine For Treatment of Post-operative Pain From Donor Sites Following Burn Injury.

NCT02229578 ↗

Phase 4 Completed 34 enrolled University of Florida
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Burn pain is known to be one the most severe forms of acute pain often requiring large amounts of narcotics in addition to other adjuvants. Topical lidocaine is effective for controlling pain in various settings including dressing changes of burns. The aim of this study is to demonstrate the effectiveness of topical lidocaine in decreasing pain scores and narcotic requirements when applied to donor graft sites while at the same time not interfering with the standard of care TheraBond dressing. During this study the investiagtors will be monitoring for evidence of delayed wound healing, and surgical site infection.

Timeline

Start
2014-09
Primary completion
2017-11-14
Completion
2017-11-14

Outcome

Missed primary endpoint

registry analysis (superiority test); Lidocaine Treatment Group vs Placebo Treatment Group; p <0.05; Mean Difference (Final Values) 0.45 (95% CI -1.2 to 2.1); t-test, 2 sided NCT02229578 ↗

registry analysis (superiority test); Lidocaine Treatment Group vs Placebo Treatment Group; p <0.05; Mean Difference (Final Values) -0.14 (95% CI -1.77 to 1.49); t-test, 2 sided NCT02229578 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 7 mg/kg Topical

Indications

No indication recorded.