Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Adenotonsillectomy
  • Opioid Use
  • Post Operative Analgesia
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Experimental, open-label randomized control trial.Masking: None (Open Label)Masking Description: Open labelPrimary Purpose: Treatment

Participation Requirements

Age
Between 3 years and 17 years
Gender
Both males and females

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 intracaps...

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.

Tracking Information

NCT #
NCT04791761
Collaborators
Not Provided
Investigators
Principal Investigator: David H Chi, MD Clinical Director, Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh