Indomethacin and Cardiac Bypass Surgery

Phase 4

Completed

• Conditions: Hemorrhage
• Interventions: Drug: Acetaminophen; Drug: Acetaminophen & Indomethacin; Drug: Indomethacin

• Registration Number: NCT01073670
• Lead Sponsor: Queen's University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08
• Primary Completion: 2002-04
• Study Completion: 2002-04
• Status Verified: 2010-02
• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-22
• Last Update Submitted: 2010-02-22
• Study First Posted: 2010-02-23
• Last Update Posted: 2010-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen	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.
Combination	Acetaminophen & Indomethacin	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.
Indomethacin	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.

Primary Outcome Measures

Name	Time	Method
amount of blood lost via chest drains during and following cardiac bypass surgery	during surgery and then until chest drains removed (< 24 hours)

Secondary Outcome Measures

Name	Time	Method
blood clotting indices (i.e., conventional and using thromboelastography)	perioperative period until 24 hours post-operative
Morphine equivalents required to provide effective analgesia	perioperative period until 24 hours post-operative	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	perioperative period until 24 hours post-operative	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.

Trial Locations

Locations (1)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada