Complication of InjectionPhase 4NCT01401049
Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol
A Phase 4 study testing Fospropofol and Propofol/Lidocaine in people with Complication of Injection and Pain, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Complication of Injection, Pain
- What is being tested?
- Fospropofol and Propofol/Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jan 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) I, II or III.
- Age 18 - 65.
- Both male and female.
- No significant laboratory abnormalities.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
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).
Read the 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
- Being tested
- Fospropofol, Propofol/Lidocaine
- Keywords
- Fospropofol, Propofol, Colonoscopy, Lusedra
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called Propofol, Fospropofol, Pain on Injection
We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion).
| Study group | Role | What they receive |
|---|---|---|
| Fospropofol | Experimental | 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. Receives: Drug: Fospropofol |
| Propofol/Lidocaine | Active comparator | 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). Receives: Drug: Propofol/Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Incidence and Intensity of Pain on Injection That is Caused by Propofol (Lipid Emulsion) Versus the Test Drug Fospropofol.
We hypothesize that we can reject the null hypothesis that results from all 3 arms are from the same sample, and then show (in pair wise tests) that fospropofol is superior to propofol, and not-inferior to propofol plus lidocaine.
Measured: 2 hours
Secondary outcomes (1)
To Compare Patient Satisfaction With Sedation Including the Recall of Pain.
We hypothesize that we can reject the null hypothesis that results from all 3 arms are from the same sample, and then show (in pair wise tests) that fospropofol is superior to propofol, and not-inferior to propofol plus lidocaine.
Measured: 2 hours after the end of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startAug 2010
- Primary completionJul 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Complication of InjectionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Mitchell Lee, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401049
- Sponsor's protocol ID
- 09-0742
- Status last verified
- Dec 2017
- First submitted
- 17 Jun 2011
- Last updated
- 29 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol
- ClinicalTrials.gov ID
- NCT01401049
- Acronym / sponsor ID
- 09-0742
- Conditions
- Complication of Injection, Pain
- Keywords
- Fospropofol, Propofol, Colonoscopy, Lusedra
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Aug 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Posted 26 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fospropofol | Experimental | Drug: FospropofolTo 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 | Active comparator | Drug: Propofol/LidocaineThe 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) I, II or III.
- Age 18 - 65.
- Both male and female.
- No significant laboratory abnormalities.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FospropofolTo 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 | Fospropofol |
| Propofol/LidocaineAlso: Propofol, Fospropofol, Pain on InjectionWe plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion). | Drug | Propofol/Lidocaine |
Primary outcome
Compare Incidence and Intensity of Pain on Injection That is Caused by Propofol (Lipid Emulsion) Versus the Test Drug Fospropofol.
Time frame: 2 hours
We hypothesize that we can reject the null hypothesis that results from all 3 arms are from the same sample, and then show (in pair wise tests) that fospropofol is superior to propofol, and not-inferior to propofol plus lidocaine.
1 secondary outcome
To Compare Patient Satisfaction With Sedation Including the Recall of Pain.
Time frame: 2 hours after the end of the procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Lee, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fospropofol and Propofol/Lidocaine in people with Complication of Injection and Pain, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Incidence and Intensity of Pain on Injection That is Caused by Propofol (Lipid Emulsion) Versus the Test Drug Fospropofol. (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2017.