| September 7, 2005 |
| May 12, 2009 |
| January 2004 |
| June 2006 (final data collection date for primary outcome measure) |
| Total morphine administered [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: No ] |
- total morphine administered;
- chest tube drainage;
- immediate post-op platelet count;
- pain/sedation/nausea assessments;
- total blood given, including PRBC, Platelets, FFP;
- new on-set of A-fib.
|
| Complete list of historical versions of study NCT00161577 on ClinicalTrials.gov Archive Site |
- Chest tube drainage [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: Yes ]
- Respiratory Assessments (NIF, VC) [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: No ]
- VAS Pain Scale [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: No ]
|
- blood gases including FiO2;
- respiratory assessments.
|
| |
| Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery |
| 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. |
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. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Pain Management Following Cardiopulmonary Bypass Surgery |
- Drug: Ketorolac
- Other: Placebo
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| Other: Group A = Ketorolac |
| |
| |
| Completed |
| 25 |
| June 2006 |
| June 2006 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
|
| Both |
| 18 Years to 75 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00161577 |
| Gregory Kerr, MD, Weill Cornell Medical College |
| 0903-886 |
| Weill Medical College of Cornell University |
|
| Principal Investigator: |
Gergory Kerr, M.D., MBA |
Weill Medical College of Cornell University, New York Presbyterian Hospital |
|
|
| Weill Medical College of Cornell University |
| May 2009 |