Clinical trial NCT04791761: Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy
Official title: Use of a Non-Opioid Pain Regimen for Post-Operative Analgesia Following Intracapsular Adenotonsillectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Adenotonsillectomy
Post-operative Analgesia
Opioid Use
Keywords: analgesia
pain control
adenotonsillectomy
tonsillectomy
opioids
post-operative pain
intracapsular
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 73
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental, open-label randomized control trial.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average Pain Burden
timeFrame: 14 days post-operatively
Secondary outcomes:
measure: ED (Emergency Department) or Urgent Care Visits
timeFrame: 14 days post-operatively
Other outcomes:
measure: Number of Readmissions
timeFrame: 14 days post-operatively
measure: Frequency of Each Analgesic Used
timeFrame: 14 days post-operatively
measure: Duration of Each Analgesic Used
timeFrame: 14 days post-operatively
measure: Pain Relief Satisfaction
timeFrame: 14 days post-operatively
measure: Post-operative Nursing Phone Calls
timeFrame: 14 days post-operatively
measure: Night-time Awakenings
timeFrame: 14 days post-operatively
measure: Non-opioid Group Switching to Opioid Group
timeFrame: 14 days post-operatively
measure: Need for Follow-up Appointment
timeFrame: two months post-operatively
measure: Household Income
timeFrame: 14 days post-operatively
measure: Education Level
timeFrame: 14 days post-operatively
measure: Side Effects of Medications
timeFrame: 14 days post-operatively
measure: Use of the Opioid Disposal Pouch
timeFrame: Up until the return of the pain diary within 8 weeks of the surgery
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Clinical Director, Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh
name: David H Chi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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