CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 116 enrolled
Drug / intervention
Fospropofol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01401049
NCT01401049Phase 4Completed
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Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol

NYU Langone Health·interventional·Posted Jul 25, 2011·Updated Dec 29, 2017

In Brief

A Phase 4 clinical trial evaluating Fospropofol and Propofol/Lidocaine for Complication of Injection and Pain. Completed, enrolled 116 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplication of Injection, Pain
CountriesUnited States
CollaboratorsEisai Inc.

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 25, 2011
Enrollment StartAug 1, 2010
Primary CompletionJul 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.9 years ago

Interventions

Fospropofoldrug

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/Lidocainedrug

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