Non-opioids for Analgesia After Adenotonsillectomy in Children
NCT ID: NCT03618823
Last Updated: 2021-11-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
268 participants
INTERVENTIONAL
2018-10-25
2020-05-18
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Opioid pain control
Patients in this group will be receiving triple therapy for pain control with oxycodone, acetaminophen, and ibuprofen. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the pain diary.
Oxycodone
Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
Ibuprofen
Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
Acetaminophen
Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
Non-opioid pain control
Patients in this group will be receiving therapy for pain control with acetaminophen and ibuprofen only. They will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. The diary will be completed by post-operative day 14. A post-operative appointment between 4-8 weeks will be scheduled and the patient and caregiver will return the diary.
Ibuprofen
Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
Acetaminophen
Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
Interventions
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Oxycodone
Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
Ibuprofen
Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
Acetaminophen
Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
3 Years
17 Years
ALL
Yes
Sponsors
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David Chi, MD
OTHER
Responsible Party
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David Chi, MD
Associate Professor
Principal Investigators
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David H Chi, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Director, Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh
Locations
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UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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References
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Van Cleve WC, Grigg EB. Variability in opioid prescribing for children undergoing ambulatory surgery in the United States. J Clin Anesth. 2017 Sep;41:16-20. doi: 10.1016/j.jclinane.2017.05.014. Epub 2017 Jun 3.
Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1.
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.
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.
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.
Holte K, Kehlet H. Effect of postoperative epidural analgesia on surgical outcome. Minerva Anestesiol. 2002 Apr;68(4):157-61.
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.
Bean-Lijewski JD, Kruitbosch SH, Hutchinson L, Browne B. Post-tonsillectomy pain management in children: can we do better? Otolaryngol Head Neck Surg. 2007 Oct;137(4):545-51. doi: 10.1016/j.otohns.2007.06.731.
Luk LJ, Mosen D, MacArthur CJ, Grosz AH. Implementation of a Pediatric Posttonsillectomy Pain Protocol in a Large Group Practice. Otolaryngol Head Neck Surg. 2016 Apr;154(4):720-4. doi: 10.1177/0194599815627810. Epub 2016 Feb 16.
Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.
Whelan RL, McCoy JL, Mirson L, Maguire RC, Jabbour N, Simons JP, Dohar JE, Kitsko DJ, Stapleton AL, Tobey ABJ, Alper CM, Shaffer AD, Bennett ZR, Chi DH. Opioid Analgesia Following Pediatric Adenotonsillectomy: A Randomized Clinical Trial. Otolaryngol Head Neck Surg. 2025 Aug;173(2):392-401. doi: 10.1002/ohn.1280. Epub 2025 May 21.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY19040036 (Part 1)
Identifier Type: -
Identifier Source: org_study_id