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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401049
• Other study ID #: 09-0742
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2011
• Last updated: December 4, 2017
• Start date: August 2010
• Est. completion date: January 2013

Study information

• Verified date: December 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: January 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) I, II or III.

• Age 18 - 65.

• Both male and female.

• No significant laboratory abnormalities.

Exclusion Criteria:

• Chronic pain patients or patients receiving benzodiazepines or opioids / other analgesics for control of acute pain will be excluded.

• Patients with known allergies to any of the study drugs, or to soybean oil or egg lecithin are excluded.

• Women with a positive pregnancy test reported from pre-surgical testing or their physician's office or who are breast feeding at the time of surgery.

• No emergency patients will be recruited for this study.

Related Conditions & MeSH terms

• Complication of Injection
• Pain

Intervention

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.
• Propofol/Lidocaine
We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion).

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare Incidence and Intensity of Pain on Injection That is Caused by Propofol (Lipid Emulsion) Versus the Test Drug Fospropofol.	We hypothesize that we can reject the null hypothesis that results from all 3 arms are from the same sample, and then show (in pair wise tests) that fospropofol is superior to propofol, and not-inferior to propofol plus lidocaine.	2 hours
Secondary	To Compare Patient Satisfaction With Sedation Including the Recall of Pain.	We hypothesize that we can reject the null hypothesis that results from all 3 arms are from the same sample, and then show (in pair wise tests) that fospropofol is superior to propofol, and not-inferior to propofol plus lidocaine.	2 hours after the end of the procedure.