Pain Management Following Cardiopulmonary Bypass SurgeryPhase 4NCT00161577
Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery
A Phase 4 study testing Ketorolac in people with Pain Management Following Cardiopulmonary Bypass Surgery, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This study evaluates the safety and efficacy of ketorolac for post-operative pain management after heart surgery. Ketorolac appears to provide enhanced pain relief while also decreasing the requirements for morphine during the (immediate) 24-hour post-operative period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain Management Following Cardiopulmonary Bypass Surgery
- What is being tested?
- Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jun 2006
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females > 18 years of age at the screening visit.
- Undergoing coronary artery bypass graft or single valve repair or replacement requiring cardiopulmonary bypass.
- American Society of Anesthesiology (ASA) Physical Class 3, or 4.
- Willing able to use a PCA Pump
- Willing to receive iv morphine for 24 hours post initial ketorolac dose to control pain.
- Capable of speaking and understanding English sufficiently to provide written informed consent and responses to pain assessment scales and neurological questionnaires.
Who cannot join
- Allergy or sensitivity to nonsteroidal anti-inflammatory drugs
- History of gastrointestinal bleeding or peptic ulcer
- Serum creatinine = 2.0 mg/dl or rise in serum creatinine of = 0.5 mg/dl or 25% within the preceding 10 days if known with the exception of patients with Dialysis Dependent End Stage Renal Disease (ESRD).
- Hepatic dysfunction
- Patients with low cardiac output syndrome (cardiac index < 2.0) after cardiopulmonary bypass or pre-op ejection fraction < 30%
- Inability to operate PCA pump
- Cardiothoracic reoperations
- Bleeding disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital, Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of Ketorolac in the Management of Post-Operative Pain After Heart Surgery
This study evaluates the safety and efficacy of ketorolac for post-operative pain management after heart surgery. Ketorolac appears to provide enhanced pain relief while also decreasing the requirements for morphine during the (immediate) 24-hour post-operative period.
Read the detailed description
Current practice at this institution does not include routine use of ketorolac for post-operative pain management of patients undergoing cardiac surgery. The investigators hypothesize that using Ketorolac as an adjunct to IV morphine can positively impact patient outcomes and reduce the occurrence of possible side effects.
- Being tested
- Ketorolac, Placebo
- Keywords
- Ketorolac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Toradol
Intravenous ketorolac every 6 hours for 24 hours
PlaceboOther
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Group A = Ketorolac Receives: Drug: Ketorolac |
| B | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine administered
Measured: 24 hours post operatively
Secondary outcomes (3)
Chest tube drainage
Measured: 24 hours post operatively
Respiratory Assessments (NIF, VC)
Measured: 24 hours post operatively
VAS Pain Scale
Measured: 24 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Management Following Cardiopulmonary Bypass SurgeryStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Investigators
- Gergory Kerr, M.D., MBA, Principal investigator, Weill Medical College of Cornell University, New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161577
- Sponsor's protocol ID
- 0903-886
- Status last verified
- May 2009
- First submitted
- 7 Sep 2005
- Last updated
- 13 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of Ketorolac in the Management of Post-Operative Pain After Heart Surgery
- ClinicalTrials.gov ID
- NCT00161577
- Acronym / sponsor ID
- 0903-886
- Keywords
- Ketorolac
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 12 Sep 2005 (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.
This study evaluates the safety and efficacy of ketorolac for post-operative pain management after heart surgery. Ketorolac appears to provide enhanced pain relief while also decreasing the requirements for morphine during the (immediate) 24-hour post-operative period.
Detailed description
Current practice at this institution does not include routine use of ketorolac for post-operative pain management of patients undergoing cardiac surgery. The investigators hypothesize that using Ketorolac as an adjunct to IV morphine can positively impact patient outcomes and reduce the occurrence of possible side effects.
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 |
|---|---|---|
| A | Other | Drug: KetorolacGroup A = Ketorolac |
| B | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females > 18 years of age at the screening visit.
- Undergoing coronary artery bypass graft or single valve repair or replacement requiring cardiopulmonary bypass.
- American Society of Anesthesiology (ASA) Physical Class 3, or 4.
- Willing able to use a PCA Pump
- Willing to receive iv morphine for 24 hours post initial ketorolac dose to control pain.
Key exclusion criteria (8 listed)
- Allergy or sensitivity to nonsteroidal anti-inflammatory drugs
- History of gastrointestinal bleeding or peptic ulcer
- Serum creatinine = 2.0 mg/dl or rise in serum creatinine of = 0.5 mg/dl or 25% within the preceding 10 days if known with the exception of patients with Dialysis Dependent End Stage Renal Disease (ESRD).
- Hepatic dysfunction
- Patients with low cardiac output syndrome (cardiac index < 2.0) after cardiopulmonary bypass or pre-op ejection fraction < 30%
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 |
|---|---|---|
| KetorolacAlso: ToradolIntravenous ketorolac every 6 hours for 24 hours | Drug | A |
| PlaceboPlacebo Comparator | Other | B |
Primary outcome
Total morphine administered
Time frame: 24 hours post operatively
3 secondary outcomes
Chest tube drainage
Time frame: 24 hours post operatively
Respiratory Assessments (NIF, VC)
Time frame: 24 hours post operatively
VAS Pain Scale
Time frame: 24 hours post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2009.
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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.
Gergory Kerr, M.D., MBA principal investigator
Weill Medical College of Cornell University, New York Presbyterian Hospital
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 Ketorolac in people with Pain Management Following Cardiopulmonary Bypass Surgery, run by Weill Medical College of Cornell University 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 6 inclusion and 8 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 13 May 2009. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total morphine administered (time frame: 24 hours post operatively). 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 13 May 2009.