Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
Conditions
Brief summary
The purpose of this study is to compare the level of pain control in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) to those receiving opioids in the postoperative period after endoscopic sinus surgery (ESS) and/or septoplasty.
Interventions
DRUGdiclofenac
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
DRUGNorco
The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* english speaking * candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist * scheduled for surgery at Texas Sinus Institute
Exclusion criteria
* allergy to either NSAIDs or opioids * contraindication to NSAIDs (ex. gastritis, chronic kidney disease) * surgical plan exceeding basic endoscopic sinus surgery * use of anticoagulation * the presence of any pain disorder * the current usage of any analgesic medication * history of opioid addiction * pregnancy * history of chronic pain or fibromyalgia * current daily use of NSAIDs, acetaminophen, opioids or other analgesics (pregabalin, tramadol, etc)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | 24 hours (day 1 after operation) | The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | 48 hours (day 2 after operation) | The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. |
| Number of Participants With Bleeding Complications | 5 days after operation | Bleeding complications are defined as complications necessitating a trip to the emergency room or requiring intervention for epistaxis. |
| Number of Participants With Constipation | 5 days after operation | — |
| Number of Participants With Nausea or Vomiting | 5 days after operation | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NSAID The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
diclofenac: The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac. | 57 |
| Opioid The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen). | 43 |
| Total | 100 |
Baseline characteristics
| Characteristic | NSAID | Opioid | Total |
|---|---|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 15.7 | 46.2 years STANDARD_DEVIATION 15.3 | 45.7 years STANDARD_DEVIATION 15.5 |
| Number of participants currently on NSAID | 1 Participants | 0 Participants | 1 Participants |
| Number of participants currently on opioid | 0 Participants | 0 Participants | 0 Participants |
| Number of participants currently on pain medication | 1 Participants | 0 Participants | 1 Participants |
| Number of participants with history of anxiety | 6 Participants | 3 Participants | 9 Participants |
| Number of participants with history of depression | 4 Participants | 3 Participants | 7 Participants |
| Number of participants with history of fibromyalgia | 0 Participants | 0 Participants | 0 Participants |
| Number of participants with history of migraine | 5 Participants | 3 Participants | 8 Participants |
| Number of participants with history of pain disorder | 0 Participants | 0 Participants | 0 Participants |
| Number of participants with history of temporomandibular joint (TMJ) dysfunction | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 57 Participants | 43 Participants | 100 Participants |
| Sex: Female, Male Female | 20 Participants | 17 Participants | 37 Participants |
| Sex: Female, Male Male | 37 Participants | 26 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 43 |
| other Total, other adverse events | 0 / 57 | 0 / 43 |
| serious Total, serious adverse events | 0 / 57 | 0 / 43 |
Outcome results
Primary
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
Time frame: 24 hours (day 1 after operation)
Population: Data was not collected for 26 in the NSAID arm and 17 in the opioid arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NSAID | Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | 30.2 units on a scale | Standard Deviation 25.3 |
| Opioid | Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | 40.7 units on a scale | Standard Deviation 29.2 |
Secondary
Number of Participants With Bleeding Complications
Bleeding complications are defined as complications necessitating a trip to the emergency room or requiring intervention for epistaxis.
Time frame: 5 days after operation
Population: Data was not collected for 27 in the NSAID arm and 19 in the opioid arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NSAID | Number of Participants With Bleeding Complications | 0 Participants |
| Opioid | Number of Participants With Bleeding Complications | 0 Participants |
Secondary
Number of Participants With Constipation
Time frame: 5 days after operation
Population: No data were collected for this outcome measure.
Secondary
Number of Participants With Nausea or Vomiting
Time frame: 5 days after operation
Population: No data were collected for this outcome measure.
Secondary
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
Time frame: 120 hours (day 5 after operation)
Population: Data was not collected for 27 in the NSAID arm and 19 in the opioid arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NSAID | Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | 17.2 units on a scale | Standard Deviation 20.3 |
| Opioid | Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | 18.9 units on a scale | Standard Deviation 18.8 |
Secondary
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
Time frame: 48 hours (day 2 after operation)
Population: Data was not collected for 25 in the NSAID arm and 16 in the opioid arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NSAID | Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | 24.2 units on a scale | Standard Deviation 25.1 |
| Opioid | Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | 28.3 units on a scale | Standard Deviation 23.4 |
Secondary
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
Time frame: 72 hours (day 3 after operation)
Population: Data was not collected for 26 in the NSAID arm and 15 in the opioid arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NSAID | Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | 22.9 units on a scale | Standard Deviation 20.4 |
| Opioid | Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) | 27.9 units on a scale | Standard Deviation 21.9 |