Pain Control After Cardiac Surgery Using Intravenous Acetaminophen

NeuroTherapia, Inc.

Status: Completed

Conditions: Pain

Treatments: Drug: Placebo; Drug: IV Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT01822821

13-269

Details and patient eligibility

About

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

Enrollment: 150 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Males or females 18 years of age or older.
• Non-emergency cardiac surgery via a midline sternotomy at Cleveland Clinic Main Campus.

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

150 participants in 2 patient groups, including a placebo group

IV Acetaminophen

Experimental group

Description:

Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.

Treatment:

Drug: IV Acetaminophen

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo