drugset / Trial / NCT00786916

Efficacy of IV Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Sedation

NCT00786916 ↗

Phase 4 Completed 109 enrolled Akron Children's Hospital
RandomizedParallel-groupTriple-blindSupportive care

Summary

This protocol describes a double-blind, placebo-controlled trial intended to demonstrate the effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term deep sedation in children. Patients will be randomized to receive either placebo (saline) or one of two dosing regimens of IV lidocaine prior to initiating propofol infusion. The efficacy of the differing lidocaine doses will be compared to determine the minimum dose required to safely achieve alleviation of pain. We hypothesize that premedicating with lidocaine will significantly decrease pain experienced by pediatric patients receiving propofol for outpatient sedation.

Timeline

Start
2008-02
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lidocaine Other / unclassified 0.25 mg/kg Intravenous
Comparator Lidocaine Other / unclassified 0.5 mg/kg Intravenous

Indications

No indication recorded.