NCT02512783

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Children's Hospitals and Clinics of Minnesota · Academic / Other
• Sex: All
• Age: 2 Months – 17 Years
• Healthy volunteers: Not accepted

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 purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.

Detailed 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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Lidocaine	Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation
DRUG	Normal Saline	Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation
DRUG	Propofol	Intravenous administration of propofol according to standard care to sedate patient.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2015-07-31
• Last updated: 2016-07-21
• Results posted: 2016-06-17

Locations

1 site across 1 country: United States