Status:

COMPLETED

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

Lead Sponsor:

NYU Langone Health

Collaborating Sponsors:

Eisai Inc.

Conditions:

Complication of Injection

Pain

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

Brief 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 ...

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...

Eligibility Criteria

Inclusion

  • American Society of Anesthesiologists (ASA) I, II or III.
  • Age 18 - 65.
  • Both male and female.
  • No significant laboratory abnormalities.

Exclusion

  • 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.

Key Trial Info

Start Date :

August 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2013

Estimated Enrollment :

116 Patients enrolled

Trial Details

Trial ID

NCT01401049

Start Date

August 1 2010

End Date

January 1 2013

Last Update

December 29 2017

Active Locations (1)

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NYU Langone Medical Center

New York, New York, United States, 10016