Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy

  • STATUS
    Recruiting
  • End date
    May 3, 2024
  • participants needed
    300
  • sponsor
    David Chi, MD
Updated on 3 May 2021

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.

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.

Details
Condition Post Operative Analgesia, Opioid Use, Postoperative Analgesia, Narcotic Use, Adenotonsillectomy, Postoperative Pain Relief, tonsillectomy with adenoidectomy
Treatment ibuprofen, Acetaminophen, Oxycodone, Opioid disposal pouch, Opioid disposal education
Clinical Study IdentifierNCT04791761
SponsorDavid Chi, MD
Last Modified on3 May 2021

Eligibility

Yes No Not Sure

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
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