Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol
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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 |
- 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.
- 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:
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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 |
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| United States, New York | |
| NYU Langone Medical Center | |
| New York, New York, United States, 10016 | |
| 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:
|
Lidocaine Propofol Fospropofol disodium Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents |
Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents Anesthetics, Intravenous Anesthetics, General Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on June 18, 2013