drugset / Trial / NCT02512783

Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation

NCT02512783 ↗

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.

Timeline

Start
2013-05
Primary completion
2014-06
Completion
2014-06

Outcome

Outcome not reported

Stopped: “Interim analysis indicated treatment was effective and statistically significant”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lidocaine Other / unclassified 1 ml —
Comparator Propofol Small molecule — Intravenous

Indications

No indication recorded.