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
1 other identifier
interventional
25
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2004
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedMay 13, 2009
May 1, 2009
2.4 years
September 7, 2005
May 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total morphine administered
24 hours post operatively
Secondary Outcomes (3)
Chest tube drainage
24 hours post operatively
Respiratory Assessments (NIF, VC)
24 hours post operatively
VAS Pain Scale
24 hours post operatively
Study Arms (2)
A
OTHERGroup A = Ketorolac
B
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York Presbyterian Hospital, Weill Cornell Medical College
New York, New York, 10021, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gergory Kerr, M.D., MBA
Weill Medical College of Cornell University, New York Presbyterian Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 12, 2005
Study Start
January 1, 2004
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
May 13, 2009
Record last verified: 2009-05