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

NCT01401049 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2017-12-29

Study results available
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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).

Conditions

  • Complication of Injection
  • Pain

Interventions

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.

DRUG

Propofol/Lidocaine

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

Sponsors & Collaborators

Principal Investigators

  • Mitchell Lee, MD · NYU Langone Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-07-31
Completion
2013-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01401049 on ClinicalTrials.gov