Pain Control After Cardiac Surgery Using Intravenous Acetaminophen

Pain Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01822821
• Other study ID #: 13-269
• Status: Active, not recruiting
• Phase: N/A
• First received: March 28, 2013
• Last updated: July 18, 2016
• Start date: March 2013
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 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
Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in opioid consumption	Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.	Day 1	No
Primary	pain intensity	Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.	Day 1	No
Secondary	adverse events	Evaluate whether IV acetaminophen reduced opioid related adverse events, duration of MV (Mechanical Ventilation), and ICU (Intensive Care Unit)and hospital LOS (Length of Stay).	Day 1	No
Secondary	duration of MV (Mechanical Ventilation)	Evaluate whether IV acetaminophen reduced opioid related adverse events, duration of MV (Mechanical Ventilation), and ICU (Intensive Care Unit)and hospital LOS (Length of Stay).	Day 1	No
Secondary	ICU (Intensive Care Unit)length of stay	Evaluate whether IV acetaminophen reduced opioid related adverse events, duration of MV (Mechanical Ventilation), and ICU (Intensive Care Unit)and hospital LOS (Length of Stay).	Day 1	No
Secondary	hospital length of stay	Evaluate whether IV acetaminophen reduced opioid related adverse events, duration of MV (Mechanical Ventilation), and ICU (Intensive Care Unit)and hospital LOS (Length of Stay).	Day 1	No
Secondary	persistent incisional pain	Evaluate whether IV acetaminophen decreases incidence of persistent incisional pain.	Day 1	No