Overview

This trial is active, not recruiting.

Condition pain
Treatments iv acetaminophen, placebo
Sponsor The Cleveland Clinic
Start date March 2013
End date December 2016
Trial size 150 participants
Trial identifier NCT01822821, 13-269

Summary

Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose supportive care
Arm
(Experimental)
Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
iv acetaminophen 1000mg IV Acetaminophen
Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
(Placebo Comparator)
Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
placebo inactive substance
Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Primary Outcomes

Measure
reduction in opioid consumption
time frame: Day 1
pain intensity
time frame: Day 1

Secondary Outcomes

Measure
adverse events
time frame: Day 1
duration of MV (Mechanical Ventilation)
time frame: Day 1
ICU (Intensive Care Unit)length of stay
time frame: Day 1
hospital length of stay
time frame: Day 1
persistent incisional pain
time frame: Day 1

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - - Males or females 18 years of age or older. - Non-emergency cardiac surgery via a midline sternotomy. Exclusion Criteria: 1. Redo cardiac surgery. 2. Combined CABG (Coronary Artery Bypass Graft)& valve replacement, multiple valve replacements, Ascending aortic or aortic arch surgery. 3. Weight < 50 Kg or Body mass index > 38 kg/m2. 4. Left ventricle EF ¡Ü 35% ,Right ventricular moderate or severe dysfunction. 5. Severe (3-4 +) Tricuspid Regurgitation. 6. Recent stroke (within 6 months). 7. Severe lung disease requiring home O2 therapy. 8. Preoperative renal insufficiency (Creatinine > 2.0) or on dialysis. 9. History of liver cirrhosis or active liver disease. 10. Chronic pain conditions controlled by preoperative opioid administration. 11. Known allergy to acetaminophen or fentanyl.

Additional Information

Principal investigator Negmeldeen Mamoun, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.