Clinical Trials Logo

Clinical Trial Summary

The goal of this study is to determine if non-opioid pain control is a safe way to manage pain after adenotonsillectomy surgery in children. The investigators will be 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 adenotonsillectomy. This may protect future children from the risks of taking opioid medications and help to reduce the scope of the opioid epidemic.


Clinical Trial Description

Purpose: To determine if non-opioid pain control is a safe and effective option in the treatment of post-operative pain following adenotonsillectomy in various pediatric age groups. Methods: The subject population will be patients between the ages of 3 and 17 who will undergo adenotonsillectomy. 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 quantity and dosage of pain medication taken each day, 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. 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. Significance: If it can be demonstrated that non-opioid pain control after 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 adenotonsillectomy. 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


Related Conditions & MeSH terms


NCT number NCT03618823
Study type Interventional
Source University of Pittsburgh
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date October 25, 2018
Completion date May 18, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT04095624 - Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion N/A
Completed NCT04484610 - Appropriate Opioid Quantities for Acute Pain - Pharmacist Study Phase 4
Recruiting NCT04598074 - Opioid Package Prototype (OPP) N/A
Recruiting NCT06033599 - Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement Phase 3
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Completed NCT05845177 - Persistent Pain After Hip Replacement
Completed NCT03570320 - Does Altering Narcotic Prescription Methods Affect Opioid Distribution Following Select Upper Extremity Surgeries? N/A
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Completed NCT04526236 - Influence of Aging on Perioperative Methadone Dosing Phase 4
Completed NCT05593341 - Opioid Education in Total Knee Arthroplasty N/A
Recruiting NCT05877157 - Pain AND Opioids After Surgery
Recruiting NCT06055205 - A Pain and Coordination Plan for Reduced Opioid Use After Accidental Injuries N/A
Recruiting NCT03675386 - Reducing Opioid Use for Chronic Pain Patients Following Surgery N/A
Suspended NCT05001789 - Cognitive Functioning in Opioid Use Disorder N/A
Completed NCT04296396 - Opioid Prescription After Cesarean Trial Phase 3
Not yet recruiting NCT04868552 - Naloxone Education in Total Joint Patients N/A
Completed NCT03540030 - Opioid-Free Shoulder Arthroplasty Phase 4
Terminated NCT06217380 - Feasibility and Acceptability of Oxygen Saturation Monitoring Using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program N/A
Recruiting NCT05976646 - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion Phase 1/Phase 2
Not yet recruiting NCT03545516 - Wound Infiltration as Part of an Opioid Free Pain Management Pathway Following Cesarean Delivery Phase 2