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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00161577

Enrollment

Registered

2005-09-12

Start date

2004-01-31

Completion date

2006-06-30

Last updated

2009-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Management Following Cardiopulmonary Bypass Surgery

Keywords

Ketorolac

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.

Interventions

DRUGKetorolac

Intravenous ketorolac every 6 hours for 24 hours

OTHERPlacebo

Placebo Comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Total morphine administered	24 hours post operatively

Secondary

Measure	Time frame
Respiratory Assessments (NIF, VC)	24 hours post operatively
VAS Pain Scale	24 hours post operatively
Chest tube drainage	24 hours post operatively

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026