PainPhase 4NCT01901393
Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery
A Phase 4 study testing IV ibuprofen and Ketorolac in people with Pain, run by Cumberland Pharmaceuticals at 4 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy of intravenous ibuprofen compared to ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- IV ibuprofen and Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2013to Aug 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for knee arthroscopy
Who cannot join
- Inadequate IV access.
- History of allergy or hypersensitivity to any component of ibuprofen, ketorolac, aspirin (or aspirin related products), non-steroidal anti-inflammatory drugs (NSAIDs), opioids or cyclooxygenase-2 (COX-2) inhibitors.
- Less than 18 years of age.
- Use of analgesics less than 8 hours prior to surgery.
- Patients with active, clinically significant anemia.
- History or evidence of asthma or heart failure.
Show all 11Show fewer
- Pregnant.
- Recent history of chronic opioid use.
- Concomitant use of probenecid.
- Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions and to return for the required assessments.
- Refusal to provide written authorization for use and disclosure of protected health information.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rush University Medical Center
Chicago, Illinois, 60612
The Ohio State University Vexner Medical Center
Columbus, Ohio, 43210
Shrock Orthopedic Research
Fort Lauderdale, Florida, 33316
North Mississippi Sports Medicine & Orthopaedic Clinic
Tupelo, Mississippi, 38801
About this study
Official title: A Multicenter, Prospective, Randomized, Double-blind Study to Determine the Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery
The purpose of this study is to assess the efficacy of intravenous ibuprofen compared to ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV ibuprofenDrug
Also called Caldolor
KetorolacDrug
Also called Ketorolac Tromethamine
| Study group | Role | What they receive |
|---|---|---|
| IV ibuprofen | Experimental | 800mg ibuprofen Receives: Drug: IV ibuprofen |
| ketorolac | Active comparator | 30mg ketorolac Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Pain Relief (Pain Intensity at Rest)
Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).
Measured: First possible time post-surgery, an expected average of 6 hours
Efficacy of Pain Relief (Pain Intensity With Movement)
Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).
Measured: First possible time post-surgery, an expected average of 6 hours
Secondary outcomes (4)
Rescue Medication Use in Post-operative Period
Amount of rescue medication (in milligrams) will be measured
Measured: Post-operative period until discharge, an expected average of 6 hours
Time to First Use of Rescue Med Will be Measured
Time to first rescue medication (in hours) in the postoperative period through discharge.
Measured: Post-operative period until discharge, an expected average of 6 hours
Patient Satisfaction
Measured using 2 question, 4 point scale.
Measured: Post-operative period until discharge, an expected average of 6 hours
Incidence of Serious Adverse Events
Number of subjects experiencing treatment-emergent serious adverse events
Measured: Post-operative period until discharge, an expected average of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2014
- Study completionAug 2014
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 PainStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur P Wheeler, MD, Study director, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901393
- Sponsor's protocol ID
- CPI-CL-020
- Status last verified
- Feb 2016
- First submitted
- 12 Jul 2013
- Last updated
- 14 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Double-blind Study to Determine the Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery
- ClinicalTrials.gov ID
- NCT01901393
- Acronym / sponsor ID
- CPI-CL-020
- Conditions
- Pain
- Keywords
- Post Operative Pain,, Pail relief
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Posted 15 Feb 2016
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 assess the efficacy of intravenous ibuprofen compared to ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV ibuprofen | Experimental | Drug: IV ibuprofen800mg ibuprofen |
| ketorolac | Active comparator | Drug: Ketorolac30mg ketorolac |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for knee arthroscopy
Key exclusion criteria (11 listed)
- Inadequate IV access.
- History of allergy or hypersensitivity to any component of ibuprofen, ketorolac, aspirin (or aspirin related products), non-steroidal anti-inflammatory drugs (NSAIDs), opioids or cyclooxygenase-2 (COX-2) inhibitors.
- Less than 18 years of age.
- Use of analgesics less than 8 hours prior to surgery.
- Patients with active, clinically significant anemia.
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 |
|---|---|---|
| IV ibuprofenAlso: Caldolor | Drug | IV ibuprofen |
| KetorolacAlso: Ketorolac Tromethamine | Drug | ketorolac |
Primary outcome
Efficacy of Pain Relief (Pain Intensity at Rest)
Time frame: First possible time post-surgery, an expected average of 6 hours
Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).
Efficacy of Pain Relief (Pain Intensity With Movement)
Time frame: First possible time post-surgery, an expected average of 6 hours
Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).
4 secondary outcomes
Rescue Medication Use in Post-operative Period
Time frame: Post-operative period until discharge, an expected average of 6 hours
Time to First Use of Rescue Med Will be Measured
Time frame: Post-operative period until discharge, an expected average of 6 hours
Patient Satisfaction
Time frame: Post-operative period until discharge, an expected average of 6 hours
Incidence of Serious Adverse Events
Time frame: Post-operative period until discharge, an expected average of 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- 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.
Arthur P Wheeler, MD study director
Cumberland Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV ibuprofen and Ketorolac in people with Pain, run by Cumberland Pharmaceuticals at 4 sites 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 1 inclusion and 11 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 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 15 Feb 2016). 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?
Efficacy of Pain Relief (Pain Intensity at Rest) (time frame: First possible time post-surgery, an expected average of 6 hours). The study lists 2 primary outcomes in all. 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 14 Mar 2016.