Narcotic Use, Opioid Abuse, Opioid Use, Otolaryngologic Disease, Pain, Postoperative Pain, Sinusitis
Conditions
Brief summary
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.
Interventions
DRUGOxyCODONE 5 Mg (milligram) Oral Tablet
Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.
DRUGIbuprofen 600 Mg (milligram) Oral Tablet
Patients in the experimental group will receive ibuprofen 600mg as the second-line analgesic.
DRUGAcetaminophen 650 MG (milligram) Oral Tablet
All patients will receive acetaminophen as the first-line analgesic.
Sponsors
Mayo Clinic
Vanderbilt University Medical Center
Albert Einstein College of Medicine
University of British Columbia
Endeavor Health
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized into one of two groups: one will receive acetaminophen and oxycodone while the other will receive acetaminophen, ibuprofen, and oxycodone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * English-speaking * Scheduled to undergo endoscopic sinus surgery for sinusitis (CRSwNP, CRSsNP, or RARS) * Can commit to follow up for at least one postoperative visit
Exclusion criteria
Patients undergoing a septorhinoplasty (septoplasty permissible if patient will also undergo sinus surgery) * Doyle splints to be used * Alcohol or opioid use disorder * History of chronic pain disorders * Regular use of acetaminophen/NSAIDS (\>4x per week) * Patients who use narcotics or neuromodulating drugs (e.g. gabapentin, nortriptyline)more than 2x per week on average. * Gastrointestinal ulcers or bleeding * Chronic kidney disease/known decreased renal function (estimated glomerular filtration rate \<60) * Liver cirrhosis or other hepatic impairment * Prior adverse reaction to opioids or NSAIDS * Other contraindications to any drug classes in either group.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity | Average pain score will be collected for preoperative visit (the day before surgery) | 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. |
| Medication Log | Postoperative day 1 to 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory (BPI) Score | BPI score will be collected at the preoperative visit | 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. |
| Severity of Epistaxis | Epistaxis severity will be collected at the preoperative visit | A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group 1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics
3. rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics | 49 |
| Control Group 1. st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours
2. nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics | 51 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 8 |
| Overall Study | Protocol Violation | 1 | 3 |
Baseline characteristics
| Characteristic | Experimental Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 16.1 | 43.3 years STANDARD_DEVIATION 15.9 | 46.7 years STANDARD_DEVIATION 16.3 |
| Lund-mackay score | 9.7 units on a scale STANDARD_DEVIATION 4.8 | 11.4 units on a scale STANDARD_DEVIATION 5.9 | 10.5 units on a scale STANDARD_DEVIATION 5.4 |
| Prior sinus surgery | 21 Participants | 18 Participants | 39 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 40 Participants | 43 Participants | 83 Participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 44 Participants |
| Sex: Female, Male Male | 27 Participants | 29 Participants | 56 Participants |
| Total baseline SNOT-22 score | 39.6 units on a scale STANDARD_DEVIATION 20.1 | 41.4 units on a scale STANDARD_DEVIATION 19.8 | 40.5 units on a scale STANDARD_DEVIATION 19.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 51 |
| other Total, other adverse events | 0 / 49 | 0 / 51 |
| serious Total, serious adverse events | 0 / 49 | 0 / 51 |
Outcome results
Primary
Medication Log
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.
Time frame: Postoperative day 1 to 7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group | Medication Log | Oxycodone POD1 | 0.3 Average number of medication doses/day | Standard Deviation 0.7 |
| Experimental Group | Medication Log | Oxycodone POD2 | 0.1 Average number of medication doses/day | Standard Deviation 0.3 |
| Experimental Group | Medication Log | Oxycodone POD3 | 0.1 Average number of medication doses/day | Standard Deviation 0.2 |
| Experimental Group | Medication Log | Oxycodone POD4 | 0.1 Average number of medication doses/day | Standard Deviation 0.3 |
| Experimental Group | Medication Log | Oxycodone POD5 | 0.1 Average number of medication doses/day | Standard Deviation 0.4 |
| Experimental Group | Medication Log | Oxycodone POD6 | 0.1 Average number of medication doses/day | Standard Deviation 0.3 |
| Experimental Group | Medication Log | Oxycodone POD7 | 0 Average number of medication doses/day | Standard Deviation 0.2 |
| Experimental Group | Medication Log | Acetaminophen POD1 | 2.0 Average number of medication doses/day | Standard Deviation 1.5 |
| Experimental Group | Medication Log | Acetaminophen POD2 | 1.8 Average number of medication doses/day | Standard Deviation 1.4 |
| Experimental Group | Medication Log | Acetaminophen POD3 | 1.3 Average number of medication doses/day | Standard Deviation 1.3 |
| Experimental Group | Medication Log | Acetaminophen POD4 | 1.0 Average number of medication doses/day | Standard Deviation 1.5 |
| Experimental Group | Medication Log | Acetaminophen POD5 | 0.9 Average number of medication doses/day | Standard Deviation 1.2 |
| Experimental Group | Medication Log | Acetaminophen POD6 | 0.9 Average number of medication doses/day | Standard Deviation 1.3 |
| Experimental Group | Medication Log | Acetaminophen POD7 | 0.6 Average number of medication doses/day | Standard Deviation 1 |
| Experimental Group | Medication Log | Ibuprofen POD1 | 0.6 Average number of medication doses/day | Standard Deviation 0.9 |
| Experimental Group | Medication Log | Ibuprofen POD2 | 0.5 Average number of medication doses/day | Standard Deviation 0.8 |
| Experimental Group | Medication Log | Ibuprofen POD3 | 0.4 Average number of medication doses/day | Standard Deviation 0.9 |
| Experimental Group | Medication Log | Ibuprofen POD4 | 0.3 Average number of medication doses/day | Standard Deviation 0.8 |
| Experimental Group | Medication Log | Ibuprofen POD5 | 0.4 Average number of medication doses/day | Standard Deviation 0.8 |
| Experimental Group | Medication Log | Ibuprofen POD6 | 0.3 Average number of medication doses/day | Standard Deviation 0.6 |
| Experimental Group | Medication Log | Ibuprofen POD7 | 0.2 Average number of medication doses/day | Standard Deviation 0.5 |
| Control Group | Medication Log | Acetaminophen POD4 | 1.5 Average number of medication doses/day | Standard Deviation 1.4 |
| Control Group | Medication Log | Oxycodone POD1 | 0.6 Average number of medication doses/day | Standard Deviation 1.1 |
| Control Group | Medication Log | Ibuprofen POD5 | 0 Average number of medication doses/day | Standard Deviation 0 |
| Control Group | Medication Log | Oxycodone POD2 | 0.4 Average number of medication doses/day | Standard Deviation 1 |
| Control Group | Medication Log | Acetaminophen POD5 | 1.3 Average number of medication doses/day | Standard Deviation 1.4 |
| Control Group | Medication Log | Oxycodone POD3 | 0.3 Average number of medication doses/day | Standard Deviation 0.8 |
| Control Group | Medication Log | Ibuprofen POD3 | 0 Average number of medication doses/day | Standard Deviation 0 |
| Control Group | Medication Log | Oxycodone POD4 | 0.3 Average number of medication doses/day | Standard Deviation 0.7 |
| Control Group | Medication Log | Acetaminophen POD6 | 1.1 Average number of medication doses/day | Standard Deviation 1.3 |
| Control Group | Medication Log | Oxycodone POD5 | 0.3 Average number of medication doses/day | Standard Deviation 1.1 |
| Control Group | Medication Log | Ibuprofen POD7 | 0 Average number of medication doses/day | Standard Deviation 0 |
| Control Group | Medication Log | Oxycodone POD6 | 0.1 Average number of medication doses/day | Standard Deviation 0.6 |
| Control Group | Medication Log | Acetaminophen POD7 | 0.6 Average number of medication doses/day | Standard Deviation 0.8 |
| Control Group | Medication Log | Oxycodone POD7 | 0 Average number of medication doses/day | Standard Deviation 0.2 |
| Control Group | Medication Log | Ibuprofen POD4 | 0 Average number of medication doses/day | Standard Deviation 0 |
| Control Group | Medication Log | Acetaminophen POD1 | 2.1 Average number of medication doses/day | Standard Deviation 1.8 |
| Control Group | Medication Log | Ibuprofen POD1 | 0 Average number of medication doses/day | Standard Deviation 0 |
| Control Group | Medication Log | Acetaminophen POD2 | 1.9 Average number of medication doses/day | Standard Deviation 1.9 |
| Control Group | Medication Log | Ibuprofen POD6 | 0 Average number of medication doses/day | Standard Deviation 0 |
| Control Group | Medication Log | Acetaminophen POD3 | 1.6 Average number of medication doses/day | Standard Deviation 1.6 |
| Control Group | Medication Log | Ibuprofen POD2 | 0 Average number of medication doses/day | Standard Deviation 0 |
Primary
Pain Severity
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.
Time frame: Average pain score will be collected for preoperative visit (the day before surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Pain Severity | 12.4 units on a scale | Standard Deviation 20 |
| Control Group | Pain Severity | 8.5 units on a scale | Standard Deviation 13.5 |
Primary
Pain Severity
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.
Time frame: Average pain score was collected for postoperative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Pain Severity | 30.2 units on a scale | Standard Deviation 26.6 |
| Control Group | Pain Severity | 29.4 units on a scale | Standard Deviation 26 |
Primary
Pain Severity
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.
Time frame: Average pain score will be collected for postoperative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Pain Severity | 8.1 units on a scale | Standard Deviation 9.8 |
| Control Group | Pain Severity | 10.1 units on a scale | Standard Deviation 11.2 |
Primary
Pain Severity
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.
Time frame: Average pain score will be collected for postoperative day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Pain Severity | 27.0 units on a scale | Standard Deviation 24.8 |
| Control Group | Pain Severity | 23.5 units on a scale | Standard Deviation 23.2 |
Primary
Pain Severity
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.
Time frame: Average pain score will be collected for postoperative day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Pain Severity | 19.2 units on a scale | Standard Deviation 22.6 |
| Control Group | Pain Severity | 22.5 units on a scale | Standard Deviation 19 |
Primary
Pain Severity
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.
Time frame: Average pain score will be collected for postoperative day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Pain Severity | 14.1 units on a scale | Standard Deviation 18.7 |
| Control Group | Pain Severity | 16.8 units on a scale | Standard Deviation 18.1 |
Primary
Pain Severity
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.
Time frame: Average pain score will be collected for postoperative day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Pain Severity | 15.8 units on a scale | Standard Deviation 21.8 |
| Control Group | Pain Severity | 15.0 units on a scale | Standard Deviation 19.6 |
Primary
Pain Severity
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.
Time frame: Average pain score will be collected for postoperative day 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Pain Severity | 13.9 units on a scale | Standard Deviation 19 |
| Control Group | Pain Severity | 11.7 units on a scale | Standard Deviation 14.5 |
Secondary
Brief Pain Inventory (BPI) Score
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.
Time frame: Average BPI score will be collected for postoperative day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Brief Pain Inventory (BPI) Score | 1.9 units on a scale | Standard Deviation 2 |
| Control Group | Brief Pain Inventory (BPI) Score | 2.1 units on a scale | Standard Deviation 1.8 |
Secondary
Brief Pain Inventory (BPI) Score
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.
Time frame: BPI score will be collected at the preoperative visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Brief Pain Inventory (BPI) Score | 1.6 units on a scale | Standard Deviation 2.2 |
| Control Group | Brief Pain Inventory (BPI) Score | 1.0 units on a scale | Standard Deviation 1.5 |
Secondary
Brief Pain Inventory (BPI) Score
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.
Time frame: Average BPI score will be collected for postoperative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Brief Pain Inventory (BPI) Score | 2.8 units on a scale | Standard Deviation 2.3 |
| Control Group | Brief Pain Inventory (BPI) Score | 2.9 units on a scale | Standard Deviation 2 |
Secondary
Brief Pain Inventory (BPI) Score
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.
Time frame: Average BPI score will be collected for postoperative day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Brief Pain Inventory (BPI) Score | 2.5 units on a scale | Standard Deviation 2.1 |
| Control Group | Brief Pain Inventory (BPI) Score | 2.3 units on a scale | Standard Deviation 2 |
Secondary
Brief Pain Inventory (BPI) Score
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.
Time frame: Average BPI score will be collected for postoperative day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Brief Pain Inventory (BPI) Score | 1.5 units on a scale | Standard Deviation 1.8 |
| Control Group | Brief Pain Inventory (BPI) Score | 1.9 units on a scale | Standard Deviation 1.6 |
Secondary
Brief Pain Inventory (BPI) Score
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.
Time frame: Average BPI score will be collected for postoperative day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Brief Pain Inventory (BPI) Score | 1.7 units on a scale | Standard Deviation 2.1 |
| Control Group | Brief Pain Inventory (BPI) Score | 1.6 units on a scale | Standard Deviation 1.6 |
Secondary
Brief Pain Inventory (BPI) Score
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.
Time frame: Average BPI score will be collected for postoperative day 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Brief Pain Inventory (BPI) Score | 1.5 units on a scale | Standard Deviation 1.9 |
| Control Group | Brief Pain Inventory (BPI) Score | 1.4 units on a scale | Standard Deviation 1.5 |
Secondary
Brief Pain Inventory (BPI) Score
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.
Time frame: Average BPI score will be collected for postoperative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Brief Pain Inventory (BPI) Score | 1.3 units on a scale | Standard Deviation 1.7 |
| Control Group | Brief Pain Inventory (BPI) Score | 1.4 units on a scale | Standard Deviation 1.5 |
Secondary
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100.
Time frame: Epistaxis severity will be collected at the preoperative visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Severity of Epistaxis | 0 units on a scale | Standard Deviation 0 |
| Control Group | Severity of Epistaxis | 0 units on a scale | Standard Deviation 0 |
Secondary
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100.
Time frame: Epistaxis severity will be collected for postoperative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Severity of Epistaxis | 36.3 units on a scale | Standard Deviation 33.2 |
| Control Group | Severity of Epistaxis | 38.9 units on a scale | Standard Deviation 31.9 |
Secondary
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100.
Time frame: Epistaxis severity will be collected for postoperative day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Severity of Epistaxis | 23.0 units on a scale | Standard Deviation 27.1 |
| Control Group | Severity of Epistaxis | 21.6 units on a scale | Standard Deviation 24 |
Secondary
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100.
Time frame: Epistaxis severity will be collected for postoperative day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Severity of Epistaxis | 15.9 units on a scale | Standard Deviation 22 |
| Control Group | Severity of Epistaxis | 12.9 units on a scale | Standard Deviation 17.5 |
Secondary
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100.
Time frame: Epistaxis severity will be collected for postoperative day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Severity of Epistaxis | 9.3 units on a scale | Standard Deviation 15.2 |
| Control Group | Severity of Epistaxis | 11.8 units on a scale | Standard Deviation 16.5 |
Secondary
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100.
Time frame: Epistaxis severity will be collected for postoperative day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Severity of Epistaxis | 10.1 units on a scale | Standard Deviation 20.1 |
| Control Group | Severity of Epistaxis | 7.8 units on a scale | Standard Deviation 17.5 |
Secondary
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100.
Time frame: Epistaxis severity will be collected for postoperative day 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Severity of Epistaxis | 6.5 units on a scale | Standard Deviation 11.6 |
| Control Group | Severity of Epistaxis | 6.6 units on a scale | Standard Deviation 14.1 |
Secondary
Severity of Epistaxis
A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100.
Time frame: Epistaxis severity will be collected for postoperative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group | Severity of Epistaxis | 4.6 units on a scale | Standard Deviation 9.2 |
| Control Group | Severity of Epistaxis | 5.4 units on a scale | Standard Deviation 12.5 |