Chronic Pelvic PainPhase 4NCT01514175
A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac
A Phase 4 study testing IV Ibuprofen and IV Ketorolac in people with Chronic Pelvic Pain, run by Culpeper Surgery Center at 1 site in United States.
Trial summary
The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of 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 to 65 years, women only
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- IV Ibuprofen and IV Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a preoperative diagnosis which is inclusive of chronic pelvic pain scheduled for Laparoscopic Surgery
Who cannot join
- Inadequate IV access.
- History of allergy or hypersensitivity to any component of IVIb,ketorolac, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors.
- Less than 18 years of age or Greater than 65 years of age.
- Use of analgesics, including NSAIDs, less than 12 hours prior to surgery.
- Patients with active, clinically significant anemia.
- History or evidence of asthma or heart failure.
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- Pregnant.
- 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.
- Patients with a history of Chronic Pain Conditions or Syndromes excluding patients with Chronic Pelvic Pain.
- Patients with known OSA
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).
Read the detailed description
The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).
The secondary objectives of this study are:
- To compare amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
- To compare time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
- To compare time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
- To compare the incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups.
- Conditions
- Chronic Pelvic Pain
- Being tested
- IV Ibuprofen, IV Ketorolac
- Keywords
- Ketorolac, Caldolor, Chronic Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV IbuprofenDrug
Also called IV Caldolor
Patients will be randomized to receive 800 mg intravenous ibuprofen or 30 mg ketorolac; each of the two treatment groups will consist of 25 patients.
IV KetorolacDrug
Also called IV Toradol
Patients will be randomized to receive 800 mg intravenous ibuprofen or 30 mg ketorolac; each of the two treatment groups will consist of 25 patients.
| Study group | Role | What they receive |
|---|---|---|
| ibuprofen versus ketoralac | Experimental | IV ibuprofen (800 mg intravenous ibuprofen administered intravenously over 10 minutes) will be administered as a single dose prior to surgery at the initiation of anesthesia. A corresponding volume of NS will be administered to the group randomized to ketorolac, at the same time to maintain the study blind. Receives: Drug: IV Ibuprofen; Drug: IV Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).
Measured: One Year
Secondary outcomes (4)
Amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
Measured: 1 Year
Time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
Measured: One Year
Time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
Measured: One Year
Incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Culpeper Surgery Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cumberland Pharmaceuticals
- Responsible party
- Principal investigator, Khalid Athar M.D., Culpeper Surgery Center
- Investigators
- Khalid Athar, MD, Principal investigator, Culpeper Regional Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514175
- Sponsor's protocol ID
- KACW1
- Status last verified
- May 2012
- First submitted
- 14 Jun 2011
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac
- ClinicalTrials.gov ID
- NCT01514175
- Acronym / sponsor ID
- KACW1
- Conditions
- Chronic Pelvic Pain
- Keywords
- Ketorolac, Caldolor, Chronic Pelvic Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Culpeper Surgery CenterUniversity, hospital or other
- Collaborators
- Cumberland Pharmaceuticals
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 23 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).
Detailed description
The primary objective of this study is to compare the efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).
The secondary objectives of this study are:
- To compare amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
- To compare time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
- To compare time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups.
- To compare the incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ibuprofen versus ketoralac | Experimental | Drug: IV Ibuprofen, Drug: IV KetorolacIV ibuprofen (800 mg intravenous ibuprofen administered intravenously over 10 minutes) will be administered as a single dose prior to surgery at the initiation of anesthesia. A corresponding volume of NS will be administered to the group randomized to ketorolac, at the same time to maintain the study blind. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a preoperative diagnosis which is inclusive of chronic pelvic pain scheduled for Laparoscopic Surgery
Key exclusion criteria (11 listed)
- Inadequate IV access.
- History of allergy or hypersensitivity to any component of IVIb,ketorolac, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors.
- Less than 18 years of age or Greater than 65 years of age.
- Use of analgesics, including NSAIDs, less than 12 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: IV CaldolorPatients will be randomized to receive 800 mg intravenous ibuprofen or 30 mg ketorolac; each of the two treatment groups will consist of 25 patients. | Drug | ibuprofen versus ketoralac |
| IV KetorolacAlso: IV ToradolPatients will be randomized to receive 800 mg intravenous ibuprofen or 30 mg ketorolac; each of the two treatment groups will consist of 25 patients. | Drug | ibuprofen versus ketoralac |
Primary outcome
The efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS).
Time frame: One Year
4 secondary outcomes
Amount of and time to rescue medication in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
Time frame: 1 Year
Time to mobility in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
Time frame: One Year
Time to discharge in the postoperative period between IV ibuprofen and IV ketorolac treatment groups
Time frame: One Year
Incidence of adverse events between IV ibuprofen and IV ketorolac treatment groups
Time frame: One Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
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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.
Khalid Athar, MD principal investigator
Culpeper Regional Health Systems
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 IV Ibuprofen and IV Ketorolac in people with Chronic Pelvic Pain, run by Culpeper Surgery Center 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 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: status not confirmed, as of the sponsor's last update on 16 May 2012. 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?
Results are not available in the source record.
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?
The efficacy of a single dose of intravenous ibuprofen compared to a single dose of ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS). (time frame: One Year). 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 16 May 2012.