Phase 4
Completed N=68
IV Acetaminophen as an Adjunct Analgesic in Cardiac Surgery
Postoperative Pain · Hyperalgesia
Source: ClinicalTrials.gov NCT01544062 ↗
Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: 24 Hour Postoperative Opioid Consumption — 62.3; 45.6 mg — p=0.024
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Patients undergoing cardiac surgery experience significant postoperative pain, which may impact postoperative outcomes. The aim of this single center, double-blind, randomized, placebo controlled trial is to determine if intravenous (IV) acetaminophen will significantly decrease 24 hour postoperative opioid consumption.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24 Hour Postoperative Opioid Consumption |
62.3; 45.6 | 0.024 sig |
| SECONDARY 48 Hour Postoperative Opioid Consumption |
105.1; 85.1 | 0.059 |
| SECONDARY 24 Hour Postoperative Pain Scores at Rest |
3.9; 3.7 | 0.724 |
| SECONDARY 48 Hour Postoperative Pain Scores at Rest |
2.4; 2.0 | 0.397 |
| SECONDARY 24 Hour Postoperative Pain Scores With Movement |
6.3; 6.0 | 0.600 |
| SECONDARY 48 Hour Postoperative Pain Scores With Movement |
5.1; 4.6 | 0.399 |
| SECONDARY 24 Hour Wound Hyperalgesia |
4.8; 4.5 | 0.771 |
| SECONDARY 48 Hour Wound Hyperalgesia |
4.6; 5.0 | 0.644 |
| SECONDARY Length of Mechanical Ventilation |
407; 360 | 0.710 |
| SECONDARY Length of ICU Stay |
67; 61 | 0.508 |
| SECONDARY 48 Hour Patient Satisfaction |
2.3; 2.8 | 0.104 |
| SECONDARY 24 Hour Nausea |
25; 26 | 0.580 |
| SECONDARY 48 Hour Nausea |
12; 14 | 0.619 |
| SECONDARY 24 Hour Pruritus |
4; 7 | 0.511 |
| SECONDARY 48 Hour Pruritus |
4; 7 | 0.501 |
| SECONDARY 24 Hour Sedation |
8; 8 | 1.000 |
| SECONDARY 48 Hour Sedation |
6; 3 | 0.299 |
| SECONDARY 24 Hour Respiratory Depression |
2; 2 | 1.000 |
| SECONDARY 48 Hour Respiratory Depression |
1; 0 | 0.492 |
| SECONDARY 24 Hour Dizziness |
20; 17 | 0.455 |
| SECONDARY 48 Hour Dizziness |
9; 10 | 1.000 |
Eligibility Criteria
Inclusion Criteria
- (1) subjects who clinically consented to elective sternotomy for coronary artery bypass grafting (CABG), heart valve repair or replacement under general anesthesia, and (2) ages between 18 and 75 years
Exclusion Criteria
- (1) subject refusal, (2) non-English speaking, (3) previous chronic or neuropathic pain, (4) previous chronic use of opioids, (5) history of psychiatric disorder, (6) allergy to acetaminophen, (7) severely impaired liver and kidney function and (8) previous sternotomy
Data sourced from ClinicalTrials.gov (NCT01544062). 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. Informational only — not medical advice.