Post-operative Pain, Sinus Surgery
Conditions
Keywords
Post-operative pain, Sinus pain, Sinus surgery, Septum Pain, deviated septum
Brief summary
This study will evaluate if the use of acetaminophen round the clock (scheduled doses) will lead to less opiate use in the first week post-operative (after surgery) in sinus/septum surgery patients. Participants will be randomized like a flip of a coin to either the standard of care pain treatment of acetaminophen 325 mg as needed for pain plus opiates (acetaminophen/hydrocodone) as needed for breakthrough pain; OR to the study arm of acetaminophen 650 mg every 6 hours plus opiates (Oxycodone)as needed for breakthrough pain.
Detailed description
Pain control in the postoperative period following septum and/or sinus surgery is controversial, as there is no consensus statement regarding current guidelines to direct clinical practice. Recent legislation limits opioid prescription length to 5 days only, which brings into question whether legislation will affect prescribing practices of physicians and whether or not giving patients an alternative to opiates will be a more efficacious route. Current prescribing practices for septum and sinus surgery of the Otolaryngology private practice group includes as-needed acetaminophen 325 mg and as-needed acetaminophen/hydrocodone 7.5 mg/325 mg. If it can be demonstrated that use of 650 mg acetaminophen in scheduled doses of every 6 hours can decrease postoperative opiate use in the first week without significantly increase in patient pain, this may be deployed as an effective strategy of pain control as the use of opiates has come under scrutiny and attempts are being made to decrease or limit the use of these medications in the medical setting. This study would look to demonstrate that scheduled doses of acetaminophen as opposed to reactionary as-needed acetaminophen can control post-operative pain to the point where narcotics would not be necessary.
Interventions
DRUGAcetaminophen 325 mg Oral Tablet
Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
Oxycodone 5 mg every 4 hours as needed for breakthrough pain
DRUGAcetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet
Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
Sponsors
Corewell Health East
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open, randomized into one of two arms study. Study arm 1: Standard of care arm of Acetaminophen (Tylenol) 325 mg every 6 hours as needed plus acetaminophen/hydrocodone 7.5 mg/325mg every 4 hours for breakthrough pain. Study arm 2: Acetaminophen 650 mg. every 6 hours round the clock plus 5 mg oxycodone every 4 hours as needed for breakthrough pain.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing primary sinus surgery, primary septum surgery, or primary sinus/septum surgery * 18 years of age or older * Male or female * No known allergies to or contraindications to the use of acetaminophen, hydrocodone, or oxycodone * Patients discharged to home after surgery
Exclusion criteria
* Undergoing revision sinus, septum, or sinus/septum surgery * Younger than 18 years old * Allergy or contraindication to acetaminophen, hydrocodone, or oxycodone * Patients admitted to the hospital postoperatively for airway monitoring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Doses of Opiate (Narcotic) Pain Medication | 7 days | Number of doses of opiates (narcotic) pain medication participants took for breakthrough pain in the first postoperative week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lowest Subjective Pain Score | 7 days | Lowest post-operative pain score during the first postoperative week as measured on an 11 point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible. |
| Percentage of Time Participant Experienced Severe Pain | 7 days | Percentage of time participant experienced severe pain requiring breakthrough pain medication during the first postoperative week, as measured on an 11 point numeric scale, from 0% to 100%, where 0% means never in severe pain and 100% means always in severe pain. |
| Participant Use of Acetaminophen as Needed | 7 days | Number of participants who took acetaminophen as needed during the first postoperative week. |
| Highest Subjective Pain Score | 7 days | Highest post-operative pain score during the first postoperative week as measured on an 11-point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible. |
| Chronic Use of Pain Medication | 7 days | Number of participants who answered Yes to the survey question, Do you take pain medication, including narcotics, for any other medical condition? |
| Participant Use of Additional Pain Medication | 7 days | Number of participants who took other pain medication (over-the-counter or narcotic) in addition to study-prescribed pain medications during first postoperative week. |
| Types of Other Pain Medication Used | 7 days | Self-reported name of pain medication (over-the-counter or narcotic) used by participants in addition to study-prescribed pain medications during the first postoperative week |
| Participant Use of Scheduled Acetaminophen Around the Clock | 7 days | Number of participants who took acetaminophen every 6 hours around the clock during first postoperative week. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Arm Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.
Acetaminophen 325 mg Oral Tablet: Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet: Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain | 34 |
| Study Arm Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.
Acetaminophen 650 mg Oral Tablet: Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
OxyCODONE 5 mg Oral Tablet: Oxycodone 5 mg every 4 hours as needed for breakthrough pain | 31 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 19 | 18 |
Baseline characteristics
| Characteristic | Study Arm | Total | Standard of Care Arm |
|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 14.26 | 44.34 years STANDARD_DEVIATION 6.79 | 34.73 years STANDARD_DEVIATION 15.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 31 participants | 65 participants | 34 participants |
| Sex: Female, Male Female | 4 Participants | 14 Participants | 10 Participants |
| Sex: Female, Male Male | 9 Participants | 14 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 13 |
| other Total, other adverse events | 0 / 15 | 0 / 13 |
| serious Total, serious adverse events | 0 / 15 | 0 / 13 |
Outcome results
Primary
Number of Doses of Opiate (Narcotic) Pain Medication
Number of doses of opiates (narcotic) pain medication participants took for breakthrough pain in the first postoperative week.
Time frame: 7 days
Population: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Arm | Number of Doses of Opiate (Narcotic) Pain Medication | 1.0 number of doses |
| Study Arm | Number of Doses of Opiate (Narcotic) Pain Medication | 1.5 number of doses |
Secondary
Chronic Use of Pain Medication
Number of participants who answered Yes to the survey question, Do you take pain medication, including narcotics, for any other medical condition?
Time frame: 7 days
Population: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Chronic Use of Pain Medication | 4 Participants |
| Study Arm | Chronic Use of Pain Medication | 2 Participants |
Secondary
Highest Subjective Pain Score
Highest post-operative pain score during the first postoperative week as measured on an 11-point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible.
Time frame: 7 days
Population: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Arm | Highest Subjective Pain Score | 6.0 score on a scale |
| Study Arm | Highest Subjective Pain Score | 5.0 score on a scale |
Secondary
Lowest Subjective Pain Score
Lowest post-operative pain score during the first postoperative week as measured on an 11 point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible.
Time frame: 7 days
Population: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Arm | Lowest Subjective Pain Score | 2.0 score on a scale |
| Study Arm | Lowest Subjective Pain Score | 2.0 score on a scale |
Secondary
Participant Use of Acetaminophen as Needed
Number of participants who took acetaminophen as needed during the first postoperative week.
Time frame: 7 days
Population: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Participant Use of Acetaminophen as Needed | 12 Participants |
| Study Arm | Participant Use of Acetaminophen as Needed | 2 Participants |
Secondary
Participant Use of Additional Pain Medication
Number of participants who took other pain medication (over-the-counter or narcotic) in addition to study-prescribed pain medications during first postoperative week.
Time frame: 7 days
Population: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Participant Use of Additional Pain Medication | 3 Participants |
| Study Arm | Participant Use of Additional Pain Medication | 1 Participants |
Secondary
Participant Use of Scheduled Acetaminophen Around the Clock
Number of participants who took acetaminophen every 6 hours around the clock during first postoperative week.
Time frame: 7 days
Population: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Participant Use of Scheduled Acetaminophen Around the Clock | 3 Participants |
| Study Arm | Participant Use of Scheduled Acetaminophen Around the Clock | 11 Participants |
Secondary
Percentage of Time Participant Experienced Severe Pain
Percentage of time participant experienced severe pain requiring breakthrough pain medication during the first postoperative week, as measured on an 11 point numeric scale, from 0% to 100%, where 0% means never in severe pain and 100% means always in severe pain.
Time frame: 7 days
Population: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Arm | Percentage of Time Participant Experienced Severe Pain | 0 percentage of time |
| Study Arm | Percentage of Time Participant Experienced Severe Pain | 0 percentage of time |
Secondary
Types of Other Pain Medication Used
Self-reported name of pain medication (over-the-counter or narcotic) used by participants in addition to study-prescribed pain medications during the first postoperative week
Time frame: 7 days
Population: 65 patients were enrolled. Data is not available for patients lost to follow up who did not complete post-operative questionnaire. 19 patients in SOC arm and 18 in study arm were lost to follow up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care Arm | Types of Other Pain Medication Used | Acetaminophen 325mg with 60mg codeine | 1 Participants |
| Standard of Care Arm | Types of Other Pain Medication Used | morphine 15mg twice daily, 25mcg fentanyl | 0 Participants |
| Standard of Care Arm | Types of Other Pain Medication Used | None | 13 Participants |
| Standard of Care Arm | Types of Other Pain Medication Used | ibuprofen | 1 Participants |
| Study Arm | Types of Other Pain Medication Used | None | 12 Participants |
| Study Arm | Types of Other Pain Medication Used | Acetaminophen 325mg with 60mg codeine | 0 Participants |
| Study Arm | Types of Other Pain Medication Used | morphine 15mg twice daily, 25mcg fentanyl | 1 Participants |
| Study Arm | Types of Other Pain Medication Used | ibuprofen | 0 Participants |