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

Completed · Phase 4 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT00786916

Run by

Akron Children's Hospital

People needed

109

Starts

2008-02-01

Expected to finish

2011-01-01

Last updated by the study team

2015-02-27

Who can join

Age: 2 and older, up to 7. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• scheduled for painless diagnostic procedures
• are ASA I or ASA II

You may not qualify if…

• have an indwelling central venous catheter
• have received an analgesic or sedative medication in the previous four hours prior to enrollment
• have an underlying chronic disorder that would impact on their ability to express distress when in painful or otherwise anxiety-provoking situations
• known hypersensitivity to lidocaine or any component of the formulation
• hypersensitivity to another local anesthetic of the amide type
• Adam-Stokes syndrome
• severe degrees of SA, AV, or intraventricular heart block
• allergy to corn-related products
• contraindication to propofol

Where it is running

• Akron Children's Hospital — Akron, Ohio, United States

Full record on ClinicalTrials.gov

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