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

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 4

Conditions: Pain Management Following Cardiopulmonary Bypass Surgery

Treatments: Other: Placebo; Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT00161577

0903-886

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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25 participants in 2 patient groups, including a placebo group

A

Other group

Description:

Group A = Ketorolac

Treatment:

Drug: Ketorolac

B

Placebo Comparator group

Treatment:

Other: Placebo