Indomethacin and Cardiac Bypass Surgery

This study has been completed.
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT01073670
First received: February 19, 2010
Last updated: February 22, 2010
Last verified: February 2010
  Purpose

Following signed informed consent, patients scheduled for elective cardiac surgery were randomly assigned to one of 3 groups to be given acetaminophen, Indomethacin or a combination of both immediately following induction and then at 6, 12, 18 & 24 hours following surgery. Our primary outcome measure was the amount of blood drained from the mediastinal tubes and chest drains. Secondary outcome measures included conventional blood coagulation indices as well as other measures of clotting as indicated by thromboelastography (TEG). Other secondary outcome measures included consumption of morphine equivalents and pain scores.


Condition Intervention Phase
Hemorrhage
Drug: Indomethacin
Drug: Acetaminophen & Indomethacin
Drug: Acetaminophen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Quantification of Postoperative Coagulation Following Administration of Indomethacin to Expedite Fast-tracking of Cardiac Surgical Patients

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • amount of blood lost via chest drains during and following cardiac bypass surgery [ Time Frame: during surgery and then until chest drains removed (< 24 hours) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • blood clotting indices (i.e., conventional and using thromboelastography) [ Time Frame: perioperative period until 24 hours post-operative ] [ Designated as safety issue: Yes ]
  • Morphine equivalents required to provide effective analgesia [ Time Frame: perioperative period until 24 hours post-operative ] [ Designated as safety issue: Yes ]
    The milligram quantities of morphine or the equivalents of morphine administered (in addition to the acetaminophen, indomethacin or combination therapy) were recorded and compared between groups. This provided an indication of how effective each of our interventions were at providing pain relief.

  • pain scores [ Time Frame: perioperative period until 24 hours post-operative ] [ Designated as safety issue: Yes ]
    Resting pain scores were recorded for all subjects at 6, 12 18 and 24 hours following surgery and compared between groups. These scores provided an indication as to the efficacy of each of our interventions at providing pain relief.


Enrollment: 82
Study Start Date: August 2000
Study Completion Date: April 2002
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acetaminophen
Participants received a loading dose of acetaminophen (2600 mg) at induction followed by 1300 mg at 6, 12, 18 and 24 hours following cardiac bypass surgery.
Drug: Acetaminophen
Subjects were given a loading dose of 2600 mg of acetaminophen (via suppository) at time of induction for anesthesia then given 1300mg at 6, 12, 18 and 24 hours following cardiac bypass surgery.
Other Name: Tylenol
Experimental: Indomethacin
Participants were given 100 mg of indomethacin at induction and then 50 mg at 6, 12, 18 and 24 hours following cardiac bypass surgery.
Drug: Indomethacin
Indomethacin was given via suppository at time of induction for anesthesia (2 x 50 mg) followed by one 50 mg suppository at 6, 12, 18 and 24 hours following cardiac bypass surgery.
Other Name: Indocin
Experimental: Combination
Participants were given a loading dose of 1300 mg of acetaminophen and 50 mg of Indomethacin followed by 650mg of acetaminophen and 25 mg of indomethacin at 6, 12, 18 and 24 hours following cardiac bypass surgery.
Drug: Acetaminophen & Indomethacin
Subjects were given a loading dose of acetaminophen (1300 mg) and indomethacin (50 mg)by suppository at the time of induction for anesthesia and then given 650mg acetaminophen + 25 mg indomethacin at 6, 12, 18 and 24 hours following cardiac bypass surgery.
Other Names:
  • Tylenol
  • Indocin

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled to undergo either elective coronary artery bypass or single valve replacement
  • normal platelet count
  • normal prothrombin time
  • normal partial thromboplastin time
  • normal serum creatinine

Exclusion Criteria:

  • sensitivity to study drugs
  • history of bleeding diathesis
  • renal dysfunction
  • active peptic ulcer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073670

Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Joel L Parlow, MD Queen's University
  More Information

No publications provided

Responsible Party: Dr. Joel Parlow, Head, Department of Anesthesiology & Perioperative Medicine, Queen's University and Kingston General Hospital
ClinicalTrials.gov Identifier: NCT01073670     History of Changes
Other Study ID Numbers: ANAE-062-00
Study First Received: February 19, 2010
Last Updated: February 22, 2010
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
NSAIDs
bleeding
thromboelastography
cardiac surgery
Indomethacin
acetaminophen

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Indomethacin
Acetaminophen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cardiovascular Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Antipyretics

ClinicalTrials.gov processed this record on October 19, 2014