A Phase 2/3 interventional study of Ibuprofen 400 mg and Acetaminophen 650 mg in Chronic Rhinosinusitis (Diagnosis), sponsored by University of Washington. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-03-22.
Sponsored by University of Washington · Phase 2/3, Interventional, and Treatment
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.
Opioid use and abuse is a major public health issue. US Surgeon General, Dr. Vikta Murthy, has recently called for investigation into evidence-based prescribing of opioids. Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the US, with about 250,000 cases performed annually.1 Currently, there is no consensus for appropriate post-operative analgesic control after ESS. Many practitioners use a combination of acetaminophen and narcotics for pain control. Importantly, most rhinologists avoid the use of NSAIDs due to a theoretical concern for decreased platelet aggregation and the potential risk of increased post-operative hemorrhage. However, no studies to date have evaluated the use of ibuprofen in CRS patients following ESS. Conceivably, if the investigators can improve post-operative pain control after ESS with using ibuprofen, then that may decrease standard prescriptions for narcotic analgesics. Given that 60% of narcotic overdose deaths are due to prescribed medications, this would help deliver improved pain control with less narcotic prescriptions. Therefore, the objective is to perform a pilot prospective cohort study to evaluate the use of narcotics in sinus surgery and the effect of ibuprofen following ESS. This pilot study will provide critical baseline data for narcotic use, ibuprofen safety and ibuprofen analgesic impact to optimize the design of a future prospective, randomized study. Thus, specific aims are as follows:
Specific Aim 1: Patients with CRS will document their narcotic use in the first 7 days following sinus surgery. This will allow us to reform prescribing practices. Hypothesis: There will be a wide range of narcotic usage among post-op patients with the mean usage being less than the amount typically prescribed post-operatively.
Specific Aim 2: During enrollment the investigators will ask patients to self-select the study arm they would like to join (ibuprofen versus no ibuprofen) thus documenting willingness to participate, which is important in designing the future randomized study. Hypothesis: Most patients approached will be wiling to participate and will indicate willingness to be part of a similar randomized study.
Specific Aim 3a: Determine impact of ibuprofen on post-operative sinus surgery patients' pain level. The investigators will analyze patients with CRS that are set to undergo ESS in two cohorts (standard pain regimen and standard pain regimen plus ibuprofen) and assess postoperative pain at days 1, 3, and 7 by 10-cm visual analogue scale, amount of post-operative narcotic pain medication used, and number of days post-operatively taking narcotic medications, Hypothesis: Addition of ibuprofen will decrease post-operative pain and will decrease number of opioid pills used.
Specific Aim 3b: Determine impact of ibuprofens impact on post-operative epistaxis. Using the same patient cohorts, degree of epistaxis will be assessed utilizing standardized recording documents and a 10-cm visual analogue scale, as well as a previously used epistaxis grading system.2 The investigators will assess these outcomes on post-operative day 1, 3, and 7. Hypothesis: Addition of ibuprofen will demonstrate no increase in post-operative epistaxis compared to the control group.
At the study institution, approximately 250 endoscopic sinus cases are performed per year performed by two rhinologists. This will yield ample potential research subjects to complete the study. To the investigators knowledge, there is one previous study looking at the effect of peri-operative NSAIDs during ESS. This study found no increased risk in intraoperative or postoperative bleeding after administration of ketorolac. This will be the first study to examine the effect of post-operative oral ibuprofen use and its effects on opioid use, as well as pain and epistaxis outcomes.
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's enrollment of 42 is below the median of 60 across 227 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
Standard pain regimen of acetaminophen 650 mg q6hrs while awake until cessation of need for scheduled pain medication with the addition of oxycodone 5 mg q3 hrs PRN (as needed) pain.
Drug: Acetaminophen 650 mg · Drug: OxyCODONE 5 Mg Oral Tablet
Alternating every 3 hours acetaminophen 650 mg and ibuprofen 400 mg while awake until cessation of need for schedule pain medication with the addition of oxycodone 5 mg q3hr PRN pain.
Drug: Ibuprofen 400 mg · Drug: Acetaminophen 650 mg · Drug: OxyCODONE 5 Mg Oral Tablet
Addition of ibuprofen to standard pain regimen.
Also known as: Motrin
Standard analgesic provided post-operatively to patients undergoing sinus surgery
Also known as: Tylenol, Paracetamol
Standard PRN medication offered post-operatively for breakthrough pain
Pain Visual Analogue Scale (VAS)
10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable.
Time frame: Post-operative day 1
Pain Visual Analogue Scale
10-cm visual analogue scale used to indicate level of post-operative pain. 10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable.
Time frame: Post-operative day 3
Pain Visual Analogue Scale
10-cm visual analogue scale used to indicate level of post-operative pain. Scale from 0-10 with 0 indicating no pain and 10 indicating worst pain imaginable.
Time frame: Post-operative day 7
Number of Opioid Pills
Number of opioid pills taken daily following surgery
Time frame: Post-operative days 1-7
Bleeding Visual Analogue Scale
10-cm visual analogue scale used to indicate amount of nasal bleeding post-operatively. 0 = no bleeding, 10 = life-threatening bleeding
Time frame: Post-operative days 1, 3, and 7
0-4 Bleeding Scale
Previously used 0-4 scale to indicate amount of nasal bleeding. 0 indicating no bleeding and 4 indicating life threatening bleeding.
Time frame: Post-operative days 1, 3, and 7
| Milestone | Control | Ibuprofen |
|---|---|---|
| Started | 16 | 26 |
| Completed | 16 | 26 |
| Not completed | 0 | 0 |
10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable.
| units on a scale | Control | Ibuprofen |
|---|---|---|
| Pain Visual Analogue Scale (VAS) | 3.3 ± 2.1 | 2.3 ± 2.1 |
10-cm visual analogue scale used to indicate level of post-operative pain. 10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable.
| units on a scale | Control | Ibuprofen |
|---|---|---|
| Pain Visual Analogue Scale | 3.0 ± 2.1 | 1.7 ± 1.4 |
10-cm visual analogue scale used to indicate level of post-operative pain. Scale from 0-10 with 0 indicating no pain and 10 indicating worst pain imaginable.
| units on the pain visual analogue scale | Control | Ibuprofen |
|---|---|---|
| Pain Visual Analogue Scale | 3.3 ± 2.1 | 2.3 ± 2.1 |
Number of opioid pills taken daily following surgery
| pills per day | Control | Ibuprofen |
|---|---|---|
| Number of Opioid Pills | 4 ± 1 | 4 ± 1 |
10-cm visual analogue scale used to indicate amount of nasal bleeding post-operatively. 0 = no bleeding, 10 = life-threatening bleeding
| units on a scale | Control | Ibuprofen |
|---|---|---|
| Post-operative day 1 | 3.2 ± 2.0 | 2.3 ± 2.1 |
| Post-operative day 3 | 3.2 ± 2.1 | 2.3 ± 1.8 |
| Post-operative day 7 | 1.2 ± 0.6 | 0.5 ± 1.1 |
Previously used 0-4 scale to indicate amount of nasal bleeding. 0 indicating no bleeding and 4 indicating life threatening bleeding.
| score on a scale | Control | Ibuprofen |
|---|---|---|
| Post-operative day 1 | 1.5 ± 1.0 | 0.9 ± 0.6 |
| Post-operative day 3 | 1.5 ± 1.0 | 0.9 ± 0.6 |
| Post-operative day 7 | 0.7 ± 0.6 | 0.3 ± 0.5 |
Number of changes to post-operative wound dressing. This outcome was not collected based on difficulty with patient compliance. No data was gathered on this outcome measure.
No measurements were reported for this outcome.
Collected over Adverse events were collected over the study period, which included the 7 days following sinus surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Ibuprofen | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Age, Continuous(years) | Control | Ibuprofen | Total |
|---|---|---|---|
| Mean | 45 ± 16 | 53 ± 18.5 | 49 ± 17 |
| Sex: Female, Male(Participants) | Control | Ibuprofen | Total |
|---|---|---|---|
| Female | 8 | 14 | 22 |
| Male | 8 | 12 | 20 |
| Race and Ethnicity Not Collected(Participants) | Control | Ibuprofen | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Control | Ibuprofen | Total |
|---|---|---|---|
| United States | 16 | 26 | 42 |
| Chronic rhinonsinusitis (CRS) with Nasal Polyposis(Participants) | Control | Ibuprofen | Total |
|---|---|---|---|
| Count of participants | 1 | 12 | 13 |
| Duration of surgery(minutes) | Control | Ibuprofen | Total |
|---|---|---|---|
| Mean | 90 ± 44.2 | 91 ± 49.1 | 90 ± 46 |
| Estimated blood loss(milliliters) | Control | Ibuprofen | Total |
|---|---|---|---|
| Mean | 49 ± 34.7 | 51 ± 22.6 | 51 ± 30 |
| Lund-MacKay CT grading Score(units on a scale) | Control | Ibuprofen | Total |
|---|---|---|---|
| Mean | 9.4 ± 6 | 10.1 ± 6 | 9.8 ± 6 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — There is no plan to share IPD
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