Clinical trial NCT00161577: Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain Management Following Cardiopulmonary Bypass Surgery
Keywords: Ketorolac
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total morphine administered
timeFrame: 24 hours post operatively
Secondary outcomes:
measure: Chest tube drainage
timeFrame: 24 hours post operatively
measure: Respiratory Assessments (NIF, VC)
timeFrame: 24 hours post operatively
measure: VAS Pain Scale
timeFrame: 24 hours post operatively
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital, Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University, New York Presbyterian Hospital
name: Gergory Kerr, M.D., MBA
role: PRINCIPAL_INVESTIGATOR
References: