N/A
N=150
Pain Control After Cardiac Surgery Using Intravenous Acetaminophen
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01822821 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Cumulative Opioid Consumption — 97; 117 mg morphine equivalents — p=0.08
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IV Acetaminophen (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Opioid Consumption |
97; 117 | 0.08 |
| PRIMARY Pain Intensity |
3.1; 4.0; 4.6; 5.0; 3.5; 4.4 | < 0.001 sig |
| SECONDARY Postoperative Nausea and Vomiting |
16; 21 | 0.35 |
| SECONDARY Postoperative Sedation |
0; 0; 0; 0; 0; 0 | 0.13 |
| SECONDARY Duration of Mechanical Ventilation (Minutes) |
214; 190 | 0.46 |
| SECONDARY Intensive Care Unit (ICU) Length of Stay |
214; 190 | 0.38 |
| SECONDARY Hospital Length of Stay |
6.2; 6.1 | 0.12 |
| SECONDARY Alanine Aminotransferase (ALT); U/L |
18; 19; 18; 19; 17; 18 | 0.31 |
| SECONDARY Aspartate Aminotransferase (AST); U/L |
35; 33; 40; 40; 31; 31 | 0.98 |
| SECONDARY Total Bilirubin (mg/dL) |
0.7; 0.7; 0.7; 0.7; 0.6; 0.6 | 0.40 |
Summary
Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.
Eligibility Criteria
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
- Redo cardiac surgery.
- Combined CABG (Coronary Artery Bypass Graft)& valve replacement, multiple valve replacements, Ascending aortic or aortic arch surgery.
- Weight 38 kg/m2.
- Left ventricle EF ¡Ü 35% , Right ventricular moderate or severe dysfunction.
- Severe (3-4 +) Tricuspid Regurgitation.
- Recent stroke (within 6 months).
- Severe lung disease requiring home O2 therapy.
- Preoperative renal insufficiency (Creatinine > 2.0) or on dialysis.
- History of liver cirrhosis or active liver disease.
- Chronic pain conditions controlled by preoperative opioid administration.
- Known allergy to acetaminophen or fentanyl.
Data sourced from ClinicalTrials.gov (NCT01822821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.