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Saint Paul, Minnesota 55102


Purpose:

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 parent will then be asked to rate the child's discomfort using the visual analog 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.


Study summary:

Propofol is a short-acting, intravenously administered anesthetic. It has become a popular choice for procedural sedation in both children and adults. Despite its many advantages, Propofol is associated with a burning sensation during injection. Propofol pain begins within the first few seconds after administration and often lasts approximately 10-20 seconds until the patient is asleep. Lidocaine is often used in an attempt to reduce Propofol injection pain, but neither its delivery mode nor concentration has been standardized. The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol. 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 FLACC scale. The parent will then be asked to rate the child's discomfort using the visual analog scale.


Criteria:

Inclusion Criteria: - age 2 months to 17 years - patient already scheduled for procedural sedation with propofol - sedation procedure to be performed by a sedationist from Children's Respiratory and Critical Care Specialists Exclusion Criteria: - patients who are not receiving deep sedation with propofol - patients with allergy or other contraindication to lidocaine administration - patients with central venous catheters as propofol does not burn when given centrally - patients being premedicated with an analgesic other than nitrous oxide or 1% lidocaine - patients weighing less than 5 kg to prevent any risk of inadvertent lidocaine overdose.


NCT ID:

NCT02512783


Primary Contact:

Principal Investigator
Didima Mon-Sprehe, MD
Children's Hospitals and Clinics of Minnesota


Backup Contact:

N/A


Location Contact:

Saint Paul, Minnesota 55102
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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