Adenotonsillectomy, Opioid Use, Post-operative Analgesia
Conditions
Keywords
analgesia, pain control, adenotonsillectomy, tonsillectomy, opioids, post-operative pain
Brief summary
The goal of this study is to determine if non-opioid pain control is a safe way to manage pain after adenotonsillectomy surgery in children. The investigators will be randomly assigning children aged 3-17 to one of two groups: one group will receive non-opioid pain medication only, and the other group will receive opioid and non-opioid medications for pain control. The investigators will analyze the data and determine if there is a difference in pain control between the two drug regimens, and if there are any other associated complications between the two groups. This study is important because if we can demonstrate that there is little difference in outcomes and pain control between the two groups, a strong argument can be made for reducing or eliminating opioid prescription after adenotonsillectomy. This may protect future children from the risks of taking opioid medications and help to reduce the scope of the opioid epidemic.
Detailed description
Purpose: To determine if non-opioid pain control is a safe and effective option in the treatment of post-operative pain following adenotonsillectomy in various pediatric age groups. Methods: The subject population will be patients between the ages of 3 and 17 who will undergo adenotonsillectomy. The study will consist of two unblinded arms - patients receiving standard pain control regimen which include opioids and non-opioids, and patients receiving non-opioid pain medications only. In the diary they will receive, patients or caregivers will record quantity and dosage of pain medication taken each day, a survey, and pain ratings measured by the Wong-Baker FACES Pain Rating Scale. Within 4-8 weeks post-operatively the patients will return for a follow up appointment along with their diary. Demographic information such as age, race, gender, household income will be extracted from the diary and the electronic medical record. Information such as surgical technique, concurrent operations, post-operative pain prescription (types, weight based dosage, and total days prescribed) will be extracted from the electronic medical record and recorded as well. Outcomes measured will include pain scale rating and rates of complications between the two groups. Significance: If it can be demonstrated that non-opioid pain control after adenotonsillectomy does not lead to increased pain or worse outcomes in certain pediatric age groups, a strong argument can be made for the cessation of opioid prescription for these ages following adenotonsillectomy. Given the widespread opioid epidemic, this would be a significant step in curbing the massive opioid problem, as well as reducing the adverse effects of opioid usage in pediatric populations.
Interventions
DRUGOxycodone
Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
DRUGIbuprofen
Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
DRUGAcetaminophen
Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
Sponsors
David Chi, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label
Intervention model description
Experimental, open-label randomized control trial.
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
• Patients age 3 - 17 undergoing adenotonsillectomy
Exclusion criteria
* Down syndrome * History of coagulopathy * Craniofacial abnormalities * Caregivers who cannot speak, read, or write in English proficiently * Patients who take opioids during the enrollment period * Patients who take chronic opioids * Pregnancy * Allergy to or contraindication for taking any of the study medications * Patients who have the inability to communicate * Patients who have the inability to localize pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Pain Burden | 14 days post-operatively | Average pain over 14 post-operative days before and after medications. This is quantified using the validated Wong-Baker FACES pain metric. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking pain medication. The mean of these pain ratings will be the primary outcome measure. The Wong-Baker FACES scale is from 0 (min) to 10 (max). A higher score indicates worse outcome/pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Side Effects of Medications | 14 days post-operatively | Number of any of the following side effects experienced: Nausea, vomiting, constipation, stomach ache, difficulty breathing. Assessed at follow-up and take-home pain diary. |
| Number of Participants With ED (Emergency Department) or Urgent Care Visits | 14 days post-operatively | Number of participants with emergency department or urgent care visits in 14 post-operative days - assessed via the electronic medical record and the take-home pain diary. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Average Dose of Each Analgesic Used | 14 days post-operatively | In the take-home pain diary, patients will record the amount of medication taken for each dose. The mean value of these doses will be calculated and averaged within each group to determine the average dose of each analgesic used. |
| Duration of Each Analgesic Used | 14 days post-operatively | Using the results of the take-home pain diary, we will calculate the average number of days of use of each analgesic for each group. The last day after which there is no subsequent use of analgesic will define the end-point of the duration of use. |
| Mean of Total Quantity of Pain Medications Taken | 14 days post-operatively | Using the take-home pain diary, the total amount in mL of each analgesic used over 14 days by each patient in a group will be averaged and reported. |
| Overall Pain Relief Satisfaction | 14 days post-operatively | Score assigned by the patient at the end of 14 post-operative days in the take-home pain diary using a Likert scale. Patients will respond to the following statement I am happy with the pain relief I received in the last 14 days with responses ranging from strongly agree to strongly disagree. The responses will be assigned a numerical value, from 0 (strongly disagree) to 4 (strongly agree), and the average value for all subjects in the group will be reported as the overall pain relief satisfaction. Higher scores mean a better outcome. |
| Post-operative Nursing Phone Calls | 14 days post-operatively | Number of post-operative phone calls to nursing staff, obtained using the electronic medical record. |
| Number of Night-time Awakenings | 14 days post-operatively | Number of night-time awakenings reported in 14 days - assessed via the take-home pain diary. |
| Non-opioid Group Switching to Opioid Group | 14 days post-operatively | Number of non-opioid group members switching to receiving opioid medication - assessed via the take-home pain diary. |
| Need for Follow-up Appointment | two months post-operatively | Does the parent/guardian believe his/her child would require a follow-up appointment - assessed using the individual pain diary. |
| Household Income | 14 days post-operatively | Total household income ranges will be assessed in the take-home pain diary and reported. |
| Education Level | 14 days post-operatively | Using the take-home pain diary, parents/guardians of the patients will identify the highest level of education achieved by anyone in the household. |
| Number of Participants With Readmissions | 14 days post-operatively | Number of participants with hospitalizations after discharge in 14 days - assessed using the electronic medical record and the take-home pain diary. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Opioid Pain Control Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone: Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours. | 132 |
| Non-opioid Pain Control Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen: Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses.
Acetaminophen: Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours. | 136 |
| Total | 268 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 63 | 61 |
Baseline characteristics
| Characteristic | Opioid Pain Control | Non-opioid Pain Control | Total |
|---|---|---|---|
| Age, Continuous | 8.39 Years STANDARD_DEVIATION 3.33 | 8.15 Years STANDARD_DEVIATION 3.33 | 8.27 Years STANDARD_DEVIATION 3.32 |
| BMI Centile | 66.42 Percentage STANDARD_DEVIATION 32.81 | 67.20 Percentage STANDARD_DEVIATION 31.44 | 66.81 Percentage STANDARD_DEVIATION 32.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 127 Participants | 120 Participants | 247 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 11 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 11 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 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 | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 118 Participants | 120 Participants | 238 Participants |
| Sex: Female, Male Female | 69 Participants | 68 Participants | 137 Participants |
| Sex: Female, Male Male | 63 Participants | 68 Participants | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 149 | 0 / 119 |
| other Total, other adverse events | 38 / 149 | 22 / 119 |
| serious Total, serious adverse events | 9 / 149 | 4 / 119 |
Outcome results
Primary
Average Pain Burden
Average pain over 14 post-operative days before and after medications. This is quantified using the validated Wong-Baker FACES pain metric. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking pain medication. The mean of these pain ratings will be the primary outcome measure. The Wong-Baker FACES scale is from 0 (min) to 10 (max). A higher score indicates worse outcome/pain.
Time frame: 14 days post-operatively
Population: Participants were analyzed for average pain burden if they completed the take-home pain diary and pain scores were recorded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Opioid Pain Control Group | Average Pain Burden | Before | 5.78 Score on a scale | Standard Error 0.25 |
| Opioid Pain Control Group | Average Pain Burden | After | 2.33 Score on a scale | Standard Error 0.22 |
| Non-opioid Pain Control Group | Average Pain Burden | Before | 5.66 Score on a scale | Standard Error 0.23 |
| Non-opioid Pain Control Group | Average Pain Burden | After | 2.24 Score on a scale | Standard Error 0.21 |
Comparison: There will be no difference in pain scores between opioid and non-opioid groups from before medication to after while controlling for total duration of mediation use (duration mean=10.11 days).p-value: 0.912Mixed Models Analysis
Secondary
Number of Participants With ED (Emergency Department) or Urgent Care Visits
Number of participants with emergency department or urgent care visits in 14 post-operative days - assessed via the electronic medical record and the take-home pain diary.
Time frame: 14 days post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opioid Pain Control Group | Number of Participants With ED (Emergency Department) or Urgent Care Visits | 8 Participants |
| Non-opioid Pain Control Group | Number of Participants With ED (Emergency Department) or Urgent Care Visits | 11 Participants |
Comparison: There will be no difference in ED (Emergency Department) or urgent care visits between opioid and non-opioid pain control groups.p-value: 0.6395% CI: [0.494, 3.478]Fisher Exact
Secondary
Number of Side Effects of Medications
Number of any of the following side effects experienced: Nausea, vomiting, constipation, stomach ache, difficulty breathing. Assessed at follow-up and take-home pain diary.
Time frame: 14 days post-operatively
Population: Participants were analyzed for side effects of medications if they completed the take-home pain diary and side effects of medications were recorded.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Opioid Pain Control Group | Number of Side Effects of Medications | 3 side effect | 9 Participants |
| Opioid Pain Control Group | Number of Side Effects of Medications | 0 side effect | 38 Participants |
| Opioid Pain Control Group | Number of Side Effects of Medications | 4 side effect | 1 Participants |
| Opioid Pain Control Group | Number of Side Effects of Medications | 2 side effect | 7 Participants |
| Opioid Pain Control Group | Number of Side Effects of Medications | 5 side effect | 0 Participants |
| Opioid Pain Control Group | Number of Side Effects of Medications | 1 side effect | 10 Participants |
| Non-opioid Pain Control Group | Number of Side Effects of Medications | 5 side effect | 0 Participants |
| Non-opioid Pain Control Group | Number of Side Effects of Medications | 1 side effect | 22 Participants |
| Non-opioid Pain Control Group | Number of Side Effects of Medications | 2 side effect | 7 Participants |
| Non-opioid Pain Control Group | Number of Side Effects of Medications | 3 side effect | 2 Participants |
| Non-opioid Pain Control Group | Number of Side Effects of Medications | 4 side effect | 0 Participants |
| Non-opioid Pain Control Group | Number of Side Effects of Medications | 0 side effect | 35 Participants |
Other Pre-specified
Average Dose of Each Analgesic Used
In the take-home pain diary, patients will record the amount of medication taken for each dose. The mean value of these doses will be calculated and averaged within each group to determine the average dose of each analgesic used.
Time frame: 14 days post-operatively
Population: Participants who took mg dose instead of ml for acetaminophen and ibuprofen were taken out of the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Opioid Pain Control Group | Average Dose of Each Analgesic Used | Acetaminophen | 6.54 Milliliters | Standard Deviation 2.87 |
| Opioid Pain Control Group | Average Dose of Each Analgesic Used | Ibuprofen | 7.53 Milliliters | Standard Deviation 4.08 |
| Opioid Pain Control Group | Average Dose of Each Analgesic Used | Oxycodone | 0.13 Milliliters | Standard Deviation 0.19 |
| Non-opioid Pain Control Group | Average Dose of Each Analgesic Used | Acetaminophen | 7.52 Milliliters | Standard Deviation 6.47 |
| Non-opioid Pain Control Group | Average Dose of Each Analgesic Used | Ibuprofen | 7.53 Milliliters | Standard Deviation 4.74 |
| Non-opioid Pain Control Group | Average Dose of Each Analgesic Used | Oxycodone | 0.04 Milliliters | Standard Deviation 0.24 |
Other Pre-specified
Duration of Each Analgesic Used
Using the results of the take-home pain diary, we will calculate the average number of days of use of each analgesic for each group. The last day after which there is no subsequent use of analgesic will define the end-point of the duration of use.
Time frame: 14 days post-operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Opioid Pain Control Group | Duration of Each Analgesic Used | Acetaminophen | 8.61 days | Standard Deviation 2.97 |
| Opioid Pain Control Group | Duration of Each Analgesic Used | Ibuprofen | 8.49 days | Standard Deviation 3.42 |
| Opioid Pain Control Group | Duration of Each Analgesic Used | Oxycodone | 2.62 days | Standard Deviation 2.9 |
| Non-opioid Pain Control Group | Duration of Each Analgesic Used | Acetaminophen | 8.64 days | Standard Deviation 3.4 |
| Non-opioid Pain Control Group | Duration of Each Analgesic Used | Ibuprofen | 8.75 days | Standard Deviation 3.46 |
| Non-opioid Pain Control Group | Duration of Each Analgesic Used | Oxycodone | 0.45 days | Standard Deviation 1.66 |
Other Pre-specified
Education Level
Using the take-home pain diary, parents/guardians of the patients will identify the highest level of education achieved by anyone in the household.
Time frame: 14 days post-operatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Opioid Pain Control Group | Education Level | High school degree | 4 Participants |
| Opioid Pain Control Group | Education Level | College degree | 18 Participants |
| Opioid Pain Control Group | Education Level | Some high school | 0 Participants |
| Opioid Pain Control Group | Education Level | Master's degree | 14 Participants |
| Opioid Pain Control Group | Education Level | Vocational or associate degree | 7 Participants |
| Opioid Pain Control Group | Education Level | Professional or academic doctorate | 4 Participants |
| Opioid Pain Control Group | Education Level | No response | 14 Participants |
| Opioid Pain Control Group | Education Level | Prefer not to answer | 1 Participants |
| Opioid Pain Control Group | Education Level | Some college | 7 Participants |
| Non-opioid Pain Control Group | Education Level | Prefer not to answer | 1 Participants |
| Non-opioid Pain Control Group | Education Level | No response | 13 Participants |
| Non-opioid Pain Control Group | Education Level | Some high school | 3 Participants |
| Non-opioid Pain Control Group | Education Level | High school degree | 8 Participants |
| Non-opioid Pain Control Group | Education Level | Vocational or associate degree | 10 Participants |
| Non-opioid Pain Control Group | Education Level | Some college | 4 Participants |
| Non-opioid Pain Control Group | Education Level | College degree | 24 Participants |
| Non-opioid Pain Control Group | Education Level | Master's degree | 9 Participants |
| Non-opioid Pain Control Group | Education Level | Professional or academic doctorate | 3 Participants |
Other Pre-specified
Household Income
Total household income ranges will be assessed in the take-home pain diary and reported.
Time frame: 14 days post-operatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Opioid Pain Control Group | Household Income | $200,000 or more | 2 Participants |
| Opioid Pain Control Group | Household Income | No response | 14 Participants |
| Opioid Pain Control Group | Household Income | $0-25,000 | 2 Participants |
| Opioid Pain Control Group | Household Income | $25,001-50,000 | 8 Participants |
| Opioid Pain Control Group | Household Income | $50,001-75,000 | 9 Participants |
| Opioid Pain Control Group | Household Income | $75,001-100,000 | 11 Participants |
| Opioid Pain Control Group | Household Income | $100,001-125,000 | 9 Participants |
| Opioid Pain Control Group | Household Income | $125,001-150,000 | 3 Participants |
| Opioid Pain Control Group | Household Income | $150,001-175,000 | 1 Participants |
| Opioid Pain Control Group | Household Income | $175,001-200,000 | 7 Participants |
| Opioid Pain Control Group | Household Income | Prefer not to answer | 3 Participants |
| Non-opioid Pain Control Group | Household Income | Prefer not to answer | 11 Participants |
| Non-opioid Pain Control Group | Household Income | $25,001-50,000 | 7 Participants |
| Non-opioid Pain Control Group | Household Income | $100,001-125,000 | 6 Participants |
| Non-opioid Pain Control Group | Household Income | No response | 13 Participants |
| Non-opioid Pain Control Group | Household Income | $175,001-200,000 | 5 Participants |
| Non-opioid Pain Control Group | Household Income | $0-25,000 | 7 Participants |
| Non-opioid Pain Control Group | Household Income | $125,001-150,000 | 3 Participants |
| Non-opioid Pain Control Group | Household Income | $200,000 or more | 2 Participants |
| Non-opioid Pain Control Group | Household Income | $50,001-75,000 | 11 Participants |
| Non-opioid Pain Control Group | Household Income | $150,001-175,000 | 1 Participants |
| Non-opioid Pain Control Group | Household Income | $75,001-100,000 | 9 Participants |
Other Pre-specified
Mean of Total Quantity of Pain Medications Taken
Using the take-home pain diary, the total amount in mL of each analgesic used over 14 days by each patient in a group will be averaged and reported.
Time frame: 14 days post-operatively
Population: Participants who took mg dose instead of ml for acetaminophen and ibuprofen were taken out of the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Opioid Pain Control Group | Mean of Total Quantity of Pain Medications Taken | Acetaminophen | 292.48 Milliliters | Standard Deviation 178.73 |
| Opioid Pain Control Group | Mean of Total Quantity of Pain Medications Taken | Ibuprofen | 324.14 Milliliters | Standard Deviation 225.7 |
| Opioid Pain Control Group | Mean of Total Quantity of Pain Medications Taken | Oxycodone | 6.47 Milliliters | Standard Deviation 9.89 |
| Non-opioid Pain Control Group | Mean of Total Quantity of Pain Medications Taken | Acetaminophen | 326.98 Milliliters | Standard Deviation 269.66 |
| Non-opioid Pain Control Group | Mean of Total Quantity of Pain Medications Taken | Ibuprofen | 334.65 Milliliters | Standard Deviation 234.18 |
| Non-opioid Pain Control Group | Mean of Total Quantity of Pain Medications Taken | Oxycodone | 2.96 Milliliters | Standard Deviation 14.84 |
Other Pre-specified
Need for Follow-up Appointment
Does the parent/guardian believe his/her child would require a follow-up appointment - assessed using the individual pain diary.
Time frame: two months post-operatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Opioid Pain Control Group | Need for Follow-up Appointment | No | 54 Participants |
| Opioid Pain Control Group | Need for Follow-up Appointment | No response | 7 Participants |
| Opioid Pain Control Group | Need for Follow-up Appointment | Yes | 8 Participants |
| Non-opioid Pain Control Group | Need for Follow-up Appointment | No response | 11 Participants |
| Non-opioid Pain Control Group | Need for Follow-up Appointment | No | 49 Participants |
| Non-opioid Pain Control Group | Need for Follow-up Appointment | Yes | 15 Participants |
Other Pre-specified
Non-opioid Group Switching to Opioid Group
Number of non-opioid group members switching to receiving opioid medication - assessed via the take-home pain diary.
Time frame: 14 days post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opioid Pain Control Group | Non-opioid Group Switching to Opioid Group | 7 Participants |
Other Pre-specified
Number of Night-time Awakenings
Number of night-time awakenings reported in 14 days - assessed via the take-home pain diary.
Time frame: 14 days post-operatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Opioid Pain Control Group | Number of Night-time Awakenings | Some nights (1-4) | 33 Participants |
| Opioid Pain Control Group | Number of Night-time Awakenings | Most nights (10-14) | 3 Participants |
| Opioid Pain Control Group | Number of Night-time Awakenings | None | 10 Participants |
| Opioid Pain Control Group | Number of Night-time Awakenings | No response | 4 Participants |
| Opioid Pain Control Group | Number of Night-time Awakenings | Many nights (5-9) | 19 Participants |
| Non-opioid Pain Control Group | Number of Night-time Awakenings | No response | 9 Participants |
| Non-opioid Pain Control Group | Number of Night-time Awakenings | Some nights (1-4) | 28 Participants |
| Non-opioid Pain Control Group | Number of Night-time Awakenings | Many nights (5-9) | 18 Participants |
| Non-opioid Pain Control Group | Number of Night-time Awakenings | Most nights (10-14) | 7 Participants |
| Non-opioid Pain Control Group | Number of Night-time Awakenings | None | 13 Participants |
Other Pre-specified
Number of Participants With Readmissions
Number of participants with hospitalizations after discharge in 14 days - assessed using the electronic medical record and the take-home pain diary.
Time frame: 14 days post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opioid Pain Control Group | Number of Participants With Readmissions | 3 Participants |
| Non-opioid Pain Control Group | Number of Participants With Readmissions | 8 Participants |
Other Pre-specified
Overall Pain Relief Satisfaction
Score assigned by the patient at the end of 14 post-operative days in the take-home pain diary using a Likert scale. Patients will respond to the following statement I am happy with the pain relief I received in the last 14 days with responses ranging from strongly agree to strongly disagree. The responses will be assigned a numerical value, from 0 (strongly disagree) to 4 (strongly agree), and the average value for all subjects in the group will be reported as the overall pain relief satisfaction. Higher scores mean a better outcome.
Time frame: 14 days post-operatively
Population: Participants were analyzed for overall pain relief satisfaction if they completed the take-home pain diary and overall pain relief satisfaction was recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid Pain Control Group | Overall Pain Relief Satisfaction | 3.35 score on a scale | Standard Deviation 0.79 |
| Non-opioid Pain Control Group | Overall Pain Relief Satisfaction | 3.09 score on a scale | Standard Deviation 0.96 |
Other Pre-specified
Post-operative Nursing Phone Calls
Number of post-operative phone calls to nursing staff, obtained using the electronic medical record.
Time frame: 14 days post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid Pain Control Group | Post-operative Nursing Phone Calls | 0.35 post-operative phone calls | Standard Deviation 0.66 |
| Non-opioid Pain Control Group | Post-operative Nursing Phone Calls | 0.47 post-operative phone calls | Standard Deviation 0.79 |