Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of Ketorolac in the Management of Post-Operative Pain After Heart Surgery

Conditions
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Pain Management Following Cardiopulmonary Bypass Surgery

Intervention / Treatment
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* Drug: Ketorolac
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>Group A = Ketorolac | Drug: Ketorolac<br>* Intravenous ketorolac every 6 hours for 24 hours<br>* Other names: Toradol;|
| Placebo Comparator: B<br> | Other: Placebo<br>* Placebo Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine administered |  | 24 hours post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest tube drainage |  | 24 hours post operatively | 
| Respiratory Assessments (NIF, VC) |  | 24 hours post operatively | 
| VAS Pain Scale |  | 24 hours post operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketorolac