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Pain Control Following Sinus Surgery
Phase 4 trial testing OxyCODONE 5 Mg (milligram) Oral Tablet in Sinusitis in 118 participants. Completed in 30 December 2020.
| Lead sponsor | Stanford University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 118 |
| Start date | 4 April 2019 |
| Primary completion | 1 July 2020 |
| Estimated completion | 30 December 2020 |
| Sites | 6 locations across Canada, United States |
Stanford University
18 and older, any sex, with Sinusitis or Opioid Use. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 12.4 | ± 20.0 |
| Control Group | 8.5 | ± 13.5 |
A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 30.2 | ± 26.6 |
| Control Group | 29.4 | ± 26.0 |
A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 27.0 | ± 24.8 |
| Control Group | 23.5 | ± 23.2 |
A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 19.2 | ± 22.6 |
| Control Group | 22.5 | ± 19.0 |
A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 14.1 | ± 18.7 |
| Control Group | 16.8 | ± 18.1 |
A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 15.8 | ± 21.8 |
| Control Group | 15.0 | ± 19.6 |
A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 13.9 | ± 19.0 |
| Control Group | 11.7 | ± 14.5 |
A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 8.1 | ± 9.8 |
| Control Group | 10.1 | ± 11.2 |
Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 0.3 | ± 0.7 |
| Control Group | 0.6 | ± 1.1 |
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 0.1 | ± 0.3 |
| Control Group | 0.4 | ± 1.0 |
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 0.1 | ± 0.2 |
| Control Group | 0.3 | ± 0.8 |
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 0.1 | ± 0.3 |
| Control Group | 0.3 | ± 0.7 |
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 0.1 | ± 0.4 |
| Control Group | 0.3 | ± 1.1 |
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 0.1 | ± 0.3 |
| Control Group | 0.1 | ± 0.6 |
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 0 | ± 0.2 |
| Control Group | 0 | ± 0.2 |
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 2.0 | ± 1.5 |
| Control Group | 2.1 | ± 1.8 |
The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 1.6 | ± 2.2 |
| Control Group | 1.0 | ± 1.5 |
The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 2.8 | ± 2.3 |
| Control Group | 2.9 | ± 2.0 |
The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 2.5 | ± 2.1 |
| Control Group | 2.3 | ± 2.0 |
Given the ongoing national opioid epidemic, an increased interest has developed in optimizing opioid prescribing practices of physicians, including otolaryngologists. Endoscopic sinus surgery (ESS) is one of the most commonly performed surgeries by otolaryngologists with over 250,000 ESS's performed annually in the U.S. Multiple studies have shown that, compared to the amount patients actually consume, otolaryngologists prescribe a high quantity of opioids to patients recovering from ESS). It has been shown that these excess opioid medications contribute to prolonged use or abuse by the patient, family members, or friends. The purpose of this study is to better understand the pain management requirements of patients who undergo ESS for recurrent acute rhinosinusitis (RARS) or chronic rhinosinusitis (CRS). This prospective, randomized, multi-institutional controlled trial will aim to determine the degree to which pain following ESS can be adequately controlled by non-opioid medications. It will also determine whether post-ESS narcotic use can be avoided entirely, or at least significantly limited. Patients will be randomized into two groups, each of which will receive a stepwise analgesic regimen consisting of acetaminophen and oxycodone or acetaminophen and ibuprofen. Pain will be assessed daily using visual analog scales (VAS) and the Brief Pain Inventory (BPI). The results of this study will help to develop a standardized approach to pain management in the post-ESS setting and help to elucidate the role of non-opioid pain medications. The ultimate goal would be to positively affect opioid prescribing patterns among surgeons who perform ESS in order to significantly reduce the quantity of opioids prescribed to patients while continuing to adequately manage patients' pain.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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