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

December 4, 2017 updated by: NYU Langone Health
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).

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10016
        • NYU Langone Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: Propofol/Lidocaine
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).
We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion).
Other Names:
  • Propofol
  • Fospropofol
  • Pain on Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare Incidence and Intensity of Pain on Injection That is Caused by Propofol (Lipid Emulsion) Versus the Test Drug Fospropofol.
Time Frame: 2 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Compare Patient Satisfaction With Sedation Including the Recall of Pain.
Time Frame: 2 hours after the end of the procedure.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Mitchell Lee, MD, NYU Langone Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

June 17, 2011

First Submitted That Met QC Criteria

July 22, 2011

First Posted (Estimate)

July 25, 2011

Study Record Updates

Last Update Posted (Actual)

December 29, 2017

Last Update Submitted That Met QC Criteria

December 4, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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