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Early termination due to COVID-19 cases and cancelled surgeries.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid pain control | Experimental | 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. |
|
| Non-opioid pain control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days post-operatively |
| Number of Side Effects of Medications |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days post-operatively |
| Average Dose of Each Analgesic Used |
Inclusion Criteria:
• Patients age 3 - 17 undergoing adenotonsillectomy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David H Chi, MD | Clinical Director, Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28802595 | Background | Van Cleve WC, Grigg EB. Variability in opioid prescribing for children undergoing ambulatory surgery in the United States. J Clin Anesth. 2017 Sep;41:16-20. doi: 10.1016/j.jclinane.2017.05.014. Epub 2017 Jun 3. | |
| 28033313 | Background | Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1. |
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Only co-investigators as listed under the University of Pittsburgh IRB (Institutional Review Board) protocol for this study will have access to all data and analysis. Data will be shared via UPMC-associated OneDrive and will only be shared between these investigators.
All data will be maintained for at least 7 years or until the child turns 23 per University of Pittsburgh policy.
All data will be shared as-needed for analysis amongst the listed co-investigators in the University of Pittsburgh IRB protocol for this study. It will be stored on the UPMC OneDrive.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants were analyzed for average pain burden if they completed the take-home pain diary and pain scores were recorded. | Posted | Mean | Standard Error | Score on a scale | 14 days post-operatively |
|
5-9 weeks depending on the date of the follow-up appointment
Number of participants at risk for adverse events was based on treatment received. The number started in the participant flow was based on group assignment.
17 of the 136 participants who were assigned to the non-opioid group received an opioid prescription upon parental request.
The number of participants at risk in the opioid group were 149 (132 assigned + 17 cross-over to opioid).
The number of participants at risk in the non-opioid group were 119 (136 assigned - 17 cross-over).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-Tonsillectomy Hemorrhage Requiring Operative Intervention | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-Tonsillectomy Hemorrhage Not Requiring Operative Intervention | Vascular disorders | Systematic Assessment |
Early termination due to COVID-19 cases and cancelled surgeries.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Research Associate | UPMC Children's Hospital of Pittsbugh | 1412-692-9879 | nelsonjl2@upmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2020 | Aug 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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Experimental, open-label randomized control trial.
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Open label
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|
| Ibuprofen | Drug | 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. |
|
| Acetaminophen | Drug | 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. |
|
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. |
| 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.
| 14 days post-operatively |
| 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. | 14 days post-operatively |
| 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. | 14 days post-operatively |
| 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. | 14 days post-operatively |
| Post-operative Nursing Phone Calls | Number of post-operative phone calls to nursing staff, obtained using the electronic medical record. | 14 days post-operatively |
| Number of Night-time Awakenings | Number of night-time awakenings reported in 14 days - assessed via the take-home pain diary. | 14 days post-operatively |
| 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. | 14 days post-operatively |
| 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. | two months post-operatively |
| Household Income | Total household income ranges will be assessed in the take-home pain diary and reported. | 14 days post-operatively |
| 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. | 14 days post-operatively |
| 28687823 | Background | Schuchat A, Houry D, Guy GP Jr. New Data on Opioid Use and Prescribing in the United States. JAMA. 2017 Aug 1;318(5):425-426. doi: 10.1001/jama.2017.8913. No abstract available. |
| 29215370 | Background | Feinberg AE, Chesney TR, Srikandarajah S, Acuna SA, McLeod RS; Best Practice in Surgery Group. Opioid Use After Discharge in Postoperative Patients: A Systematic Review. Ann Surg. 2018 Jun;267(6):1056-1062. doi: 10.1097/SLA.0000000000002591. |
| 29189368 | Background | Monitto CL, Hsu A, Gao S, Vozzo PT, Park PS, Roter D, Yenokyan G, White ED, Kattail D, Edgeworth AE, Vasquenza KJ, Atwater SE, Shay JE, George JA, Vickers BA, Kost-Byerly S, Lee BH, Yaster M. Opioid Prescribing for the Treatment of Acute Pain in Children on Hospital Discharge. Anesth Analg. 2017 Dec;125(6):2113-2122. doi: 10.1213/ANE.0000000000002586. |
| 12024074 | Background | Holte K, Kehlet H. Effect of postoperative epidural analgesia on surgical outcome. Minerva Anestesiol. 2002 Apr;68(4):157-61. |
| 29135493 | Background | van Boekel RLM, Warle MC, Nielen RGC, Vissers KCP, van der Sande R, Bronkhorst EM, Lerou JGC, Steegers MAH. Relationship Between Postoperative Pain and Overall 30-Day Complications in a Broad Surgical Population: An Observational Study. Ann Surg. 2019 May;269(5):856-865. doi: 10.1097/SLA.0000000000002583. |
| 17903568 | Background | Bean-Lijewski JD, Kruitbosch SH, Hutchinson L, Browne B. Post-tonsillectomy pain management in children: can we do better? Otolaryngol Head Neck Surg. 2007 Oct;137(4):545-51. doi: 10.1016/j.otohns.2007.06.731. |
| 26884362 | Background | Luk LJ, Mosen D, MacArthur CJ, Grosz AH. Implementation of a Pediatric Posttonsillectomy Pain Protocol in a Large Group Practice. Otolaryngol Head Neck Surg. 2016 Apr;154(4):720-4. doi: 10.1177/0194599815627810. Epub 2016 Feb 16. |
| 25624387 | Background | Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906. |
| 40396501 | Derived | Whelan RL, McCoy JL, Mirson L, Maguire RC, Jabbour N, Simons JP, Dohar JE, Kitsko DJ, Stapleton AL, Tobey ABJ, Alper CM, Shaffer AD, Bennett ZR, Chi DH. Opioid Analgesia Following Pediatric Adenotonsillectomy: A Randomized Clinical Trial. Otolaryngol Head Neck Surg. 2025 Aug;173(2):392-401. doi: 10.1002/ohn.1280. Epub 2025 May 21. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI Centile | Mean | Standard Deviation | Percentage |
|
| OG001 | Non-opioid Pain Control Group | 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. |
|
|
|
| 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. | Posted | Count of Participants | Participants | 14 days post-operatively |
|
|
|
|
| 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. | Participants were analyzed for side effects of medications if they completed the take-home pain diary and side effects of medications were recorded. | Posted | Count of Participants | Participants | 14 days post-operatively |
|
|
|
| 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. | Posted | Count of Participants | Participants | 14 days post-operatively |
|
|
|
| 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. | Participants who took mg dose instead of ml for acetaminophen and ibuprofen were taken out of the analysis. | Posted | Mean | Standard Deviation | Milliliters | 14 days post-operatively |
|
|
|
| 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. | Posted | Mean | Standard Deviation | days | 14 days post-operatively |
|
|
|
| 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. | Participants who took mg dose instead of ml for acetaminophen and ibuprofen were taken out of the analysis. | Posted | Mean | Standard Deviation | Milliliters | 14 days post-operatively |
|
|
|
| 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. | Participants were analyzed for overall pain relief satisfaction if they completed the take-home pain diary and overall pain relief satisfaction was recorded. | Posted | Mean | Standard Deviation | score on a scale | 14 days post-operatively |
|
|
|
| Other Pre-specified | Post-operative Nursing Phone Calls | Number of post-operative phone calls to nursing staff, obtained using the electronic medical record. | Posted | Mean | Standard Deviation | post-operative phone calls | 14 days post-operatively |
|
|
|
| Other Pre-specified | Number of Night-time Awakenings | Number of night-time awakenings reported in 14 days - assessed via the take-home pain diary. | Posted | Count of Participants | Participants | 14 days post-operatively |
|
|
|
| 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. | Posted | Count of Participants | Participants | 14 days post-operatively |
|
|
|
| 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. | Posted | Count of Participants | Participants | two months post-operatively |
|
|
|
| Other Pre-specified | Household Income | Total household income ranges will be assessed in the take-home pain diary and reported. | Posted | Count of Participants | Participants | 14 days post-operatively |
|
|
|
| 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. | Posted | Count of Participants | Participants | 14 days post-operatively |
|
|
|
| 0 |
| 149 |
| 9 |
| 149 |
| 38 |
| 149 |
| EG001 | 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. | 0 | 119 | 4 | 119 | 22 | 119 |
| Dehydration Requiring Inpatient Admission | General disorders | Systematic Assessment |
|
| Oxygen Desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Oxygen desaturation requiring prolongation of hospitalization for tonsillectomy and adenoidectomy |
|
| Emergency Department Visit for Pain | General disorders | Systematic Assessment |
|
| Nursing Phone Call for Pain | General disorders | Systematic Assessment |
|
| Nausea or Vomiting | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| 2 side effect |
|
| 3 side effect |
|
| 4 side effect |
|
| 5 side effect |
|
| Oxycodone |
|
| Oxycodone |
|
| Oxycodone |
|
| Many nights (5-9) |
|
| Most nights (10-14) |
|
| No response |
|
| Yes |
|
| $25,001-50,000 |
|
| $50,001-75,000 |
|
| $75,001-100,000 |
|
| $100,001-125,000 |
|
| $125,001-150,000 |
|
| $150,001-175,000 |
|
| $175,001-200,000 |
|
| $200,000 or more |
|
| Prefer not to answer |
|
| High school degree |
|
| Vocational or associate degree |
|
| Some college |
|
| College degree |
|
| Master's degree |
|
| Professional or academic doctorate |
|
| Prefer not to answer |
|