NCT01401049

Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).

Detailed description

Propofol (2,6-diisopropylphenol) is one of the most common induction and sedative agents used today. Properties that make this agent popular include rapid onset and quick recovery. However, as its use became more widespread, side effects such as pain on injection have attracted more attention. The incidence of pain on propofol injection is as high as 70 - 90%. Numerous studies report that more than 50% of patients recall the unpleasant burning sensation during injection. Many techniques to minimize pain on injection associated with propofol have been described; pre-administration of different medications including lidocaine, ketamine, thiopental, metoclopramide, dexamethasone, ondansetron, and remifentanil have been reported with mixed success. Some have even tried to use lidocaine with a tourniquet. Others have reported the use of distraction techniques including counting numbers aloud. Recently, a solvent mixture of medium chain triglyceride and long chain triglyceride has been tested for prevention of pain on propofol injection. Lusedra (fospropofol disodium), the water-soluble prodrug of propofol, does not cause pain on injection as it is water based medication. Demonstrating the benefit of fospropofol over propofol in patient satisfaction will improve acceptance by anesthesia providers.

Conditions

• Complication of Injection
• Pain

Interventions

Type	Name	Description
DRUG	Fospropofol	To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.
DRUG	Propofol/Lidocaine	We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion).

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-07-01
• Completion: 2013-01-01
• First posted: 2011-07-25
• Last updated: 2017-12-29
• Results posted: 2015-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study