Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy

Sponsor

David Chi, MD (Other)

Overall Status

Recruiting

CT.gov ID

NCT04791761

Collaborator

(none)

300

Enrollment

Location

Arms

36.6

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Adenotonsillectomy Post-operative Analgesia Opioid Use	Drug: Oxycodone Drug: Ibuprofen Drug: Acetaminophen Other: Opioid disposal pouch Other: Opioid disposal education	Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Experimental, open-label randomized control trial.Experimental, open-label randomized control trial.

Masking:

None (Open Label)

Masking Description:

Open label

Primary Purpose:

Treatment

Official Title:

Use of a Non-Opioid Pain Regimen for Post-Operative Analgesia Following Intracapsular Adenotonsillectomy

Actual Study Start Date :

Apr 13, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 or by email/mail if no appointment was scheduled. Families will receive an opioid disposal education document.	Drug: 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. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language. Drug: 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. 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. Drug: 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. 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. Other: Opioid disposal education 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.
Experimental: Opioid pain control + Disposal Pouch 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 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. Drug: 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. 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. Drug: 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. 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. Other: Opioid disposal pouch 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. Other: Opioid disposal education 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.
Active Comparator: 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 or by email/mail if no appointment was scheduled.	Drug: 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. 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. Drug: 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. 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.

Arm

Intervention/Treatment

Experimental: 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 or by email/mail if no appointment was scheduled. Families will receive an opioid disposal education document.

Drug: 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. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.

Drug: 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. 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.

Drug: 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. 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.

Other: Opioid disposal education

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.

Experimental: Opioid pain control + Disposal Pouch

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

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.

Other: Opioid disposal education

Active Comparator: 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 or by email/mail if no appointment was scheduled.

Drug: Ibuprofen

Drug: Acetaminophen

Outcome Measures

Primary Outcome Measures

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. 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.

Secondary Outcome Measures

ED (Emergency Department) or urgent care visits [14 days post-operatively]
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.

Other Outcome Measures

Number of readmissions [14 days post-operatively]
Number of hospitalizations after discharge in 14 days - assessed using the electronic medical record and the take-home pain diary.
Frequency of each analgesic used [14 days post-operatively]
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.
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.
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 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.
Post-operative nursing phone calls [14 days post-operatively]
Number of post-operative phone calls to nursing staff, obtained using the electronic medical record.
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.
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.
Use of the opioid disposal pouch [Up until the return of the pain diary within 8 weeks of the surgery]
Number of patients who reported that they used the opioid disposal pouch on the last page of the pain diary

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

• Patients age 3 - 17 undergoing adenotonsillectomy

Exclusion Criteria:

Down syndrome
History of coagulopathy
Craniofacial abnormalities other than plagiocephaly or submucous cleft palate (SMCP)
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