Phase 3
N=42
Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis
Chronic Rhinosinusitis (Diagnosis)
Bottom Line
View on ClinicalTrials.gov: NCT03055507 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Pain Visual Analogue Scale (VAS) — 3.3; 2.3 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ibuprofen 400 mg (Drug); Acetaminophen 650 mg (Drug); OxyCODONE 5 Mg Oral Tablet (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Visual Analogue Scale (VAS) |
3.3; 2.3 | <0.05 sig |
| PRIMARY Pain Visual Analogue Scale |
3.3; 2.3 | — |
| PRIMARY Pain Visual Analogue Scale |
3.3; 2.3 | — |
| SECONDARY Number of Opioid Pills |
4; 4 | — |
| SECONDARY Bleeding Visual Analogue Scale |
3.2; 2.3; 3.2; 2.3; 1.2; 0.5 | — |
| SECONDARY 0-4 Bleeding Scale |
1.5; 0.9; 1.5; 0.9; 0.7; 0.3 | — |
Summary
Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the US, with about 250,000 cases performed annually. Currently, there is no consensus, evidence-based post-operative pain regimen; with the majority of practitioners opting for a combination of acetaminophen and narcotics for pain control. Most rhinologists avoid NSAIDs due to decreased platelet aggregation and the theoretical risk of increased post-operative bleeding. No studies to date have evaluated the use of ibuprofen in CRS patients following ESS. Additionally, there is a lack of information regarding the average narcotic requirement following ESS.
The purpose of this pilot prospective cohort study is to evaluate the use of narcotics in sinus surgery and the effect of ibuprofen in the non-packed nose following ESS. This investigation will help to gain understanding of current opioid use in post-op sinus patients and assess the safety and effectiveness of post-operative ibuprofen administration on pain. The investigators aim to quantify the average narcotic use following ESS, as well as evaluate the effect of the addition of ibuprofen to the standard analgesic regimen on pain scores and post-operative epistaxis. The investigators hypothesize that the use of ibuprofen will decrease pain scores on a 10-cm visual analogue scale when compared with individuals who do not use ibuprofen post-operatively, this will lead to decreased opioid use in the post-operative period. Additionally, the investigators hypothesize no increase in post-operative bleeding rates, again based on a 10-cm visual analogue scale and bleeding events.
In summary, this will be the first study to the investigators knowledge to examine the effect of post-operative ibuprofen use and its effects on opioid use, as well as pain and epistaxis outcomes, in ESS. By performing this pilot prospective cohort study, the investigators will be equipped to design and perform the optimal prospective, randomized study evaluating the effect of NSAID in ESS during the post-operative period. The overarching goal of this investigation is to decrease opioid use in post-operative pain control following ESS.
Eligibility Criteria
Inclusion Criteria
- Patients with CRS scheduled to undergo functional endoscopic sinus surgery
- >18 years old
- Able to speak and comprehend written English
Exclusion Criteria
- Contraindication to NSAID use (Chronic kidney disease, Peptic Ulcer disease, Aspirin exacerbated respiratory disorder (AERD), etc.)
- Previous history of bleeding disorder
- Sinus cancer
- Cystic Fibrosis
- Current use of anti-coagulant or anti-platelet medication (during and immediately after ESS)
- History of chronic pain, fibromyalgia, or opioid addiction
- Excessive bleeding during the surgery as determined by the attending surgeon
- Contraindication to acetaminophen use
- Daily use of analgesics including ibuprofen, other NSAIDs, acetaminophen, narcotic medications or other analgesics.
Data sourced from ClinicalTrials.gov (NCT03055507). 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.