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

NCT ID: NCT01401049

Last Updated: 2017-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-01-31

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.

Conditions

Complication of Injection; Pain

Keywords

Fospropofol; Propofol; Colonoscopy; Lusedra

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fospropofol

Intervention Type: DRUG

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.

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).

Group Type: ACTIVE_COMPARATOR

Propofol/Lidocaine

Intervention Type: DRUG

We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion).

Interventions

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.

Intervention Type: DRUG

Propofol/Lidocaine

We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion).

Intervention Type: DRUG

Other Intervention Names

Propofol; Fospropofol; Pain on Injection

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchell Lee, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

NYU Langone Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

09-0742

Identifier Type: -

Identifier Source: org_study_id