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

Stopped early · Not applicable

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT02512783

Run by

Children's Hospitals and Clinics of Minnesota

People needed

171

Starts

2013-05-01

Expected to finish

2014-06-01

Last updated by the study team

2016-07-21

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Children's Hospitals and Clinics of Minnesota — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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