A Phase 1/2 interventional study of Oxycodone and Ibuprofen in Adenotonsillectomy, Post-operative Analgesia and Opioid Use, sponsored by David Chi, MD. Terminated at 1 site in United States. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-08-30.
Sponsored by David Chi, MD · Phase 1/2, Interventional, and Treatment
The goal of this study is to determine if non-opioid pain control is a safe way to manage pain after intracapsular adenotonsillectomy surgery in children. This study is the second part of our randomized clinical trials of assessing pain after adenotonsillectomy (T\&A), the first being total T\&A. The investigators will repeat the methodology in the first clinical trial by 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 intracapsular 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 intracapsular adenotonsillectomy in various pediatric age groups.
Methods: The subject population will be patients between the ages of 3 and 17 who will undergo intracapsular adenotonsillectomy (T\&A). Intracapsular versus total T\&A technique will be predetermined by the child's physician and will not be a part of the study. 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 frequency of pain medication taken each day with daily symptoms, 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. If the patient does not have a follow-up appointment, the families may return the pain diary by email to the research coordinator or by mail with the given postage paid envelope. 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. We will also be investigating whether or not an opioid disposal pouch helps the process of disposing any leftover opioids from the trial. We will be providing all patients in the opioid arm an opioid disposal education document and randomizing half to receive the opioid disposal pouch.
Significance: If it can be demonstrated that non-opioid pain control after intracapsular 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 this technique. 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.
David Chi, MD is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 or by email/mail if no appointment was scheduled. Families will receive an opioid disposal education document.
Drug: Oxycodone · Drug: Ibuprofen · Drug: Acetaminophen · Other: Opioid disposal education
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 or by email/mail if no appointment was scheduled. Half of the families randomized to the opioid group will be further randomized to receive an opioid disposal bag + an opioid disposal education document. The pouch is a drug deactivation disposal pouch to dispose the opioid at home.
Drug: Oxycodone · Drug: Ibuprofen · Drug: Acetaminophen · Other: Opioid disposal pouch · Other: Opioid disposal education
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 or by email/mail if no appointment was scheduled.
Drug: Ibuprofen · Drug: Acetaminophen
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.
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 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.
Half of the opioid group will be randomized assigned to an opioid disposal pouch arm. This pouch is a drug deactivation system that can be disposed in the trash in a household.
An opioid disposal education document will be provided to all families in the opioid group. This education document has information on unused or expired prescription medication disposal and specific information about permanent collection sites within our health system, drug take-back locations, drug take back day, and disposing at home.
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. The scale is from 0 to 10 with 10 being worse outcome. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking each pain medication. The mean of these pain ratings will be the primary outcome measure.
Time frame: 14 days post-operatively
ED (Emergency Department) or Urgent Care Visits
Number of 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
Number of Readmissions
Number of hospitalizations after discharge in 14 days - assessed using the electronic medical record and the take-home pain diary.
Time frame: 14 days post-operatively
Frequency of Each Analgesic Used
In the take-home pain diary, patients will place an 'x' on each time block every day that medication was given for each of the three medications. The frequencies will be summed for a total number and averaged within each group to determine the average number of times of each analgesic used.
Time frame: 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.
Time frame: 14 days post-operatively
Pain Relief Satisfaction
Score assigned by the patient at the end of 14 post-operative days in the take-home pain diary using a 5-point Likert scale of 0 (strongly disagree) to 4 (strongly agree). 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 and the average value for all subjects in the group will be reported as the overall pain relief satisfaction. Higher scores indicate a better outcome.
Time frame: 14 days post-operatively
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
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
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
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
Household Income
Total household income ranges will be assessed in the take-home pain diary and reported.
Time frame: 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.
Time frame: 14 days post-operatively
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
Use of the Opioid Disposal Pouch
Number of patients who reported that they used the opioid disposal pouch on the last page of the pain diary
Time frame: Up until the return of the pain diary within 8 weeks of the surgery
| Milestone | Opioid Pain Control | Opioid Pain Control + Disposal Pouch | Non-opioid Pain Control |
|---|---|---|---|
| Started | 21 | 16 | 36 |
| Completed | 13 | 8 | 24 |
| Not completed | 8 | 8 | 12 |
| Withdrew: Lost to follow-up | 8 | 6 | 10 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 |
| Withdrew: Protocol violation | 0 | 1 | 1 |
Average pain over 14 post-operative days before and after medications. This is quantified using the validated Wong-Baker FACES pain metric. The scale is from 0 to 10 with 10 being worse outcome. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking each pain medication. The mean of these pain ratings will be the primary outcome measure.
| score on a scale | Opioid Pain Control | Non-opioid Pain Control |
|---|---|---|
| Before Medications | 3.2 (2.5 to 3.8) | 3.3 (2.6 to 4.1) |
| After Medications | 1.1 (0.6 to 1.5) | 1.1 (0.6 to 1.5) |
Number of emergency department or urgent care visits in 14 post-operative days - assessed via the electronic medical record and the take-home pain diary.
| Participants | Opioid Pain Control | Non-opioid Pain Control |
|---|---|---|
| 0 ED or Urgent Care Visits | 36 | 33 |
| 1 ED or Urgent Care Visit | 0 | 2 |
Number of hospitalizations after discharge in 14 days - assessed using the electronic medical record and the take-home pain diary.
Results for this outcome have not been posted.
In the take-home pain diary, patients will place an 'x' on each time block every day that medication was given for each of the three medications. The frequencies will be summed for a total number and averaged within each group to determine the average number of times of each analgesic used.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Score assigned by the patient at the end of 14 post-operative days in the take-home pain diary using a 5-point Likert scale of 0 (strongly disagree) to 4 (strongly agree). 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 and the average value for all subjects in the group will be reported as the overall pain relief satisfaction. Higher scores indicate a better outcome.
Results for this outcome have not been posted.
Number of post-operative phone calls to nursing staff, obtained using the electronic medical record.
Results for this outcome have not been posted.
Number of night-time awakenings reported in 14 days - assessed via the take-home pain diary.
Results for this outcome have not been posted.
Number of non-opioid group members switching to receiving opioid medication - assessed via the take-home pain diary.
Results for this outcome have not been posted.
Does the parent/guardian believe his/her child would require a follow-up appointment - assessed using the individual pain diary.
Results for this outcome have not been posted.
Total household income ranges will be assessed in the take-home pain diary and reported.
Results for this outcome have not been posted.
Using the take-home pain diary, parents/guardians of the patients will identify the highest level of education achieved by anyone in the household.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Number of patients who reported that they used the opioid disposal pouch on the last page of the pain diary
Results for this outcome have not been posted.
Collected over 5-9 weeks depending on the date of the follow-up appointment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Opioid Pain Control | 0/21 (0%) | 0/21 (0%) | 3/21 (14.3%) |
| Opioid Pain Control + Disposal Pouch | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) |
| Non-opioid Pain Control | 0/36 (0%) | 1/36 (2.8%) | 2/36 (5.6%) |
| Event | Opioid Pain Control | Opioid Pain Control + Disposal Pouch | Non-opioid Pain Control |
|---|---|---|---|
| Post-Tonsillectomy Hemorrhage Requiring Hospital AdmissionInjury, poisoning and procedural complications | 0/21 | 0/16 | 1/36 |
| Event | Opioid Pain Control | Opioid Pain Control + Disposal Pouch | Non-opioid Pain Control |
|---|---|---|---|
| FeverGeneral disorders | 0/21 | 1/16 | 0/36 |
| Decreased Oral IntakeMetabolism and nutrition disorders | 0/21 | 0/16 | 2/36 |
| Post-Tonsillectomy Hemorrhage Not Requiring Hospital AdmissionInjury, poisoning and procedural complications | 1/21 | 0/16 | 0/36 |
| EmesisGastrointestinal disorders | 1/21 | 0/16 | 1/36 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/21 | 0/16 | 0/36 |
| Eye/Cheek EdemaGeneral disorders | 1/21 | 0/16 | 0/36 |
| NauseaGastrointestinal disorders | 0/21 | 0/16 | 1/36 |
Excludes patients withdrawn due to protocol violations.
| Age, Continuous(years) | Opioid Pain Control | Opioid Pain Control + Disposal Pouch | Non-opioid Pain Control | Total |
|---|---|---|---|---|
| Median | 4 (3 to 12) | 4 (3 to 8) | 4 (3 to 14) | 4 (3 to 14) |
| Age, Customized(Participants) | Opioid Pain Control | Opioid Pain Control + Disposal Pouch | Non-opioid Pain Control | Total |
|---|---|---|---|---|
| 3-7 years old | 18 | 13 | 31 | 62 |
| 8-12 years old | 3 | 2 | 3 | 8 |
| 13-17 years old | 0 | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Opioid Pain Control | Opioid Pain Control + Disposal Pouch | Non-opioid Pain Control | Total |
|---|---|---|---|---|
| Female | 8 | 6 | 14 | 28 |
| Male | 13 | 9 | 21 | 43 |
| Ethnicity (NIH/OMB)(Participants) | Opioid Pain Control | Opioid Pain Control + Disposal Pouch | Non-opioid Pain Control | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 18 | 14 | 32 | 64 |
| Unknown or Not Reported | 3 | 1 | 3 | 7 |
| Race (NIH/OMB)(Participants) | Opioid Pain Control | Opioid Pain Control + Disposal Pouch | Non-opioid Pain Control | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 3 | 3 |
| White | 19 | 14 | 30 | 63 |
| More than one race | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 0 | 1 | 2 |
| Region of Enrollment(participants) | Opioid Pain Control | Opioid Pain Control + Disposal Pouch | Non-opioid Pain Control | Total |
|---|---|---|---|---|
| United States | 21 | 15 | 35 | 71 |
| BMI Centile(percentile) | Opioid Pain Control | Opioid Pain Control + Disposal Pouch | Non-opioid Pain Control | Total |
|---|---|---|---|---|
| Median | 72.31 (12.03 to 99.90) | 63.37 (6.67 to 94.28) | 72.50 (2.66 to 99.94) | 69.48 (2.66 to 99.94) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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.
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David Chi, MD