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Completed

NCT Number: NCT00161577

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York Presbyterian Hospital, Weill Cornell Medical College

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac

Drug

Intravenous ketorolac every 6 hours for 24 hours

Other names: Toradol

Placebo

Other

Placebo Comparator

Primary outcomes

  1. Total morphine administered

    Time frame: 24 hours post operatively

Secondary outcomes

  1. Chest tube drainage

    Time frame: 24 hours post operatively

  2. Respiratory Assessments (NIF, VC)

    Time frame: 24 hours post operatively

  3. VAS Pain Scale

    Time frame: 24 hours post operatively

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
May 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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