N/A
Completed N=62
Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery
Chronic Sinusitis
Source: ClinicalTrials.gov NCT01608308 ↗
Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcomePrimary: Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale — 0; 0; 0; 2 units on a scale
Summary
The purpose of this study is to assess the use of IV acetaminophen (Ofirmev) as a and safe and efficacious agent in reducing post-operative pain; we hypothesize that its use will reduce post-operative pain when compared to a control group using the visual analogue score (VAS) analog pain scoring system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale |
0; 0; 0; 2 | — |
| SECONDARY Total Doses of Postoperative Opiate (Morphine) Use |
1.5; 2.5 | — |
| SECONDARY Number of Participants Who Received Intraoperative Supplemental Fentanyl |
9; 4 | — |
| SECONDARY Number of Participants Who Experienced Postoperative Morbidity (Nausea) |
13; 10 | — |
| SECONDARY Postoperative Vital Sign (Systolic Blood Pressure) |
133; 144 | — |
| SECONDARY Postoperative Vital Sign (Diastolic Blood Pressure) |
75; 78.3 | — |
| SECONDARY Postoperative Vital Sign (Pulse) |
76.3; 80 | — |
| SECONDARY Postoperative Vital Sign (Temperature) |
97.1; 97.4 | — |
| SECONDARY Postoperative Vital Sign (Respiratory Rate) |
17.4; 17.2 | — |
Eligibility Criteria
Inclusion criteria
- Patients undergoing surgical management for CRS (with or without polyps)
- Operating time must be at least 2 hours in duration.
- Number of sinuses involved must be 3 or greater
Exclusion criteria
- History of hypersensitivity to acetaminophen
- End stage renal disease
- End stage liver disease
- History of chronic pain, or use of opioid medication in the previous two weeks
- Severe depression or anxiety
- Use of gabapentin or any other pain modulator
- History of acute sinusitis or mucocele
- History of seizures
- Known or suspected history of alcohol or drug abuse
- Known or suspected history of morphine intolerance
Data sourced from ClinicalTrials.gov (NCT01608308). 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.