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

Pain Clinical Trial

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

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

• NCT number: NCT02512783
• Study type: Interventional
• Source: Children's Hospitals and Clinics of Minnesota
• Status: Terminated
• Phase: N/A
• Start date: May 2013
• Completion date: June 2014