Opioid Use Clinical Trial
Official title:
Use of a Non-Opioid Pain Regimen for Post-Operative Analgesia Following Intracapsular Adenotonsillectomy
Verified date | January 2024 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 72 |
Est. completion date | July 3, 2023 |
Est. primary completion date | July 3, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
David Chi, MD |
United States,
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Feinberg AE, Chesney TR, Srikandarajah S, Acuna SA, McLeod RS; Best Practice in Surgery Group. Opioid Use After Discharge in Postoperative Patients: A Systematic Review. Ann Surg. 2018 Jun;267(6):1056-1062. doi: 10.1097/SLA.0000000000002591. — View Citation
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Monitto CL, Hsu A, Gao S, Vozzo PT, Park PS, Roter D, Yenokyan G, White ED, Kattail D, Edgeworth AE, Vasquenza KJ, Atwater SE, Shay JE, George JA, Vickers BA, Kost-Byerly S, Lee BH, Yaster M. Opioid Prescribing for the Treatment of Acute Pain in Children on Hospital Discharge. Anesth Analg. 2017 Dec;125(6):2113-2122. doi: 10.1213/ANE.0000000000002586. — View Citation
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Schuchat A, Houry D, Guy GP Jr. New Data on Opioid Use and Prescribing in the United States. JAMA. 2017 Aug 1;318(5):425-426. doi: 10.1001/jama.2017.8913. No abstract available. — View Citation
van Boekel RLM, Warle MC, Nielen RGC, Vissers KCP, van der Sande R, Bronkhorst EM, Lerou JGC, Steegers MAH. Relationship Between Postoperative Pain and Overall 30-Day Complications in a Broad Surgical Population: An Observational Study. Ann Surg. 2019 May;269(5):856-865. doi: 10.1097/SLA.0000000000002583. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of readmissions | Number of hospitalizations after discharge in 14 days - assessed using the electronic medical record and the take-home pain diary. | 14 days post-operatively | |
Other | Frequency of each analgesic used | 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. | 14 days post-operatively | |
Other | Duration of each analgesic used | 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. | 14 days post-operatively | |
Other | Pain relief satisfaction | 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. | 14 days post-operatively | |
Other | Post-operative nursing phone calls | Number of post-operative phone calls to nursing staff, obtained using the electronic medical record. | 14 days post-operatively | |
Other | Night-time awakenings | Number of night-time awakenings reported in 14 days - assessed via the take-home pain diary. | 14 days post-operatively | |
Other | Non-opioid group switching to opioid group | Number of non-opioid group members switching to receiving opioid medication - assessed via the take-home pain diary. | 14 days post-operatively | |
Other | Need for follow-up appointment | Does the parent/guardian believe his/her child would require a follow-up appointment - assessed using the individual pain diary. | two months post-operatively | |
Other | Household income | Total household income ranges will be assessed in the take-home pain diary and reported. | 14 days post-operatively | |
Other | Education level | Using the take-home pain diary, parents/guardians of the patients will identify the highest level of education achieved by anyone in the household. | 14 days post-operatively | |
Other | Side effects of medications | 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. | 14 days post-operatively | |
Other | Use of the opioid disposal pouch | Number of patients who reported that they used the opioid disposal pouch on the last page of the pain diary | Up until the return of the pain diary within 8 weeks of the surgery | |
Primary | Average pain burden | 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. | 14 days post-operatively | |
Secondary | ED (Emergency Department) or urgent care visits | 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. | 14 days post-operatively |
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