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



Status:Terminated
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:Any - 17
Updated:4/21/2016
Start Date:May 2013
End Date:June 2014

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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.

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.

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.
We found this trial at
1
site
Saint Paul, Minnesota 55102
?
mi
from
Saint Paul, MN
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