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CompletedNCT00161577Updated May 13, 2009

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

A Phase 4 interventional study of Ketorolac and Placebo in Pain Management Following Cardiopulmonary Bypass Surgery, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-05-13.

Sponsored by Weill Medical College of Cornell University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain Management Following Cardiopulmonary Bypass Surgery

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Keywords

  • Ketorolac
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 25 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
25 participants (actual)

Study arms

  • Other
    A

    Group A = Ketorolac

    Drug: Ketorolac

  • Placebo comparator
    B

    Other: Placebo

Interventions

  • DrugKetorolac

    Intravenous ketorolac every 6 hours for 24 hours

    Also known as: Toradol

  • OtherPlacebo

    Placebo Comparator

06

What researchers measure

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

07

Study locations

1 site
  • New York Presbyterian Hospital, Weill Cornell Medical College
    New York, New York 10021, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00161577
Lead sponsor
Weill Medical College of Cornell University
First posted
Sep 12, 2005
Start date
Jan 2004
Primary completion
Jun 2006
Completion
Jun 2006
Last update
May 13, 2009

Study contacts

Gergory Kerr, M.D., MBA
principal investigator · Weill Medical College of Cornell University, New York Presbyterian Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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