- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01401049
Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10016
- NYU Langone Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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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).
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We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion).
Other Names:
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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
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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.
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2 hours
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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.
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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.
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2 hours after the end of the procedure.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mitchell Lee, MD, NYU Langone Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Membrane Transport Modulators
- Hypnotics and Sedatives
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Propofol
- Lidocaine
- Fospropofol
Other Study ID Numbers
- 09-0742
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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