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

This study has been completed.
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01401049
First received: June 17, 2011
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention Phase
Complication of Injection
Pain
Drug: Fospropofol
Drug: Propofol/Lidocaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • compare incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To compare patient satisfaction with sedation including the recall of pain. [ Time Frame: 2 hours after the end of the procedure. ] [ Designated as safety issue: No ]
    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.


Enrollment: 116
Study Start Date: August 2010
Study Completion Date: January 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other Name: Fospropofol
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).
Drug: Propofol/Lidocaine
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401049

Locations
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Eisai Inc.
Investigators
Principal Investigator: Mitchell Lee, MD NYU Langone Medical Center
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01401049     History of Changes
Other Study ID Numbers: #09-0742
Study First Received: June 17, 2011
Last Updated: February 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Fospropofol
Propofol
Colonoscopy
Lusedra

Additional relevant MeSH terms:
Fospropofol
Lidocaine
Propofol
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 20, 2014