Phase 4
Completed N=116
Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol
Complication of Injection · Postoperative Pain
Source: ClinicalTrials.gov NCT01401049 ↗
Enrolled (actual)
116
Serious AEs
—
Results posted
Jan 2015
Primary outcomePrimary: Compare Incidence and Intensity of Pain on Injection That is Caused by Propofol (Lipid Emulsion) Versus the Test Drug Fospropofol.
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).
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. |
— | — |
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. Informational only — not medical advice.