CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 42 enrolled
Drug / intervention
Ibuprofen 400 mg +2 moredrug
Likely dose
Ibuprofen 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03055507
NCT03055507Phase 3Completed

Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis: A Prospective, Pilot, Cohort Study

University of Washington·interventional·Posted Feb 16, 2017·Updated Mar 22, 2023

In Brief

A Phase 3 clinical trial evaluating Ibuprofen 400 mg, Acetaminophen 650 mg, and 1 other intervention for Chronic Rhinosinusitis (Diagnosis). Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 16, 2017
Enrollment StartApr 1, 2017
Primary CompletionDec 31, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.4 years ago

Interventions

Ibuprofen 400 mgdrug

Addition of ibuprofen to standard pain regimen.

Acetaminophen 650 mgdrug

Standard analgesic provided post-operatively to patients undergoing sinus surgery

OxyCODONE 5 Mg Oral Tabletdrug

Standard PRN medication offered post-operatively for breakthrough pain