Phase 4
N=116
Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol
Complication of Injection · Pain
Bottom Line
View on ClinicalTrials.gov: NCT01401049 ↗Enrolled (actual)
116
Serious AEs
—
Results posted
Jan 2015
Primary outcome: Primary: Compare Incidence and Intensity of Pain on Injection That is Caused by Propofol (Lipid Emulsion) Versus the Test Drug Fospropofol.
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fospropofol (Drug); Propofol/Lidocaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare Incidence and Intensity of Pain on Injection That is Caused by Propofol (Lipid Emulsion) Versus the Test Drug Fospropofol. |
— | — |
| SECONDARY To Compare Patient Satisfaction With Sedation Including the Recall of Pain. |
— | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT01401049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.