Clinical trial NCT01401049: Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol
Official title: Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Complication of Injection
Pain
Keywords: Fospropofol
Propofol
Colonoscopy
Lusedra
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Eisai Inc.
First posted: 2011-07-25
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol 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 criteria: 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.

Primary outcomes:
measure: Compare Incidence and Intensity of Pain on Injection That is Caused by Propofol (Lipid Emulsion) Versus the Test Drug Fospropofol.
timeFrame: 2 hours
Secondary outcomes:
measure: To Compare Patient Satisfaction With Sedation Including the Recall of Pain.
timeFrame: 2 hours after the end of the procedure.
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Mitchell Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: