Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery
CompletedNot applicableNCT01608308
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Double Blind, Randomized, Placebo-controlled Study to Investigate the Effectiveness of IV Acetominophen Administered During Functional Endoscopic Sinus Surgery in Reducing the Use of Opiates to Treat Postoperative Pain
- Conditions
- Chronic Sinusitis
- Interventions
- Drug: IV Acetaminophen
- Drug: Placebo
- Sponsor
- The University of Texas Health Science Center, Houston
- Collaborators
- Mallinckrodt
- Start date
- 2012-07
- Primary completion
- 2014-09
- Sex
- All
- Age range
- from 18 Years to 68 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion criteria: 1. Patients undergoing surgical management for CRS (with or without polyps) 2. Operating time must be at least 2 hours in duration. 3. Number of sinuses involved must be 3 or greater Exclusion criteria: 1. History of hypersensitivity to acetaminophen 2. End stage renal disease 3. End stage liver disease 4. History of chronic pain, or use of opioid medication in the previous two weeks 5. Severe depression or anxiety 6. Use of gabapentin or any other pain modulator 7. History of acute sinusitis or mucocele 8. History of seizures 9. Known or suspected history of alcohol or drug abuse 10. Known or suspected history of morphine intolerance
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01608308