Non-opioids for Analgesia After Adenotonsillectomy in Children

NCT03618823 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: STUDY19040036 (Part 1)
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenotonsillectomy; Post-operative Analgesia; Opioid Use

Keywords

analgesia; pain control; adenotonsillectomy; tonsillectomy; opioids; post-operative pain

Outcome Measures

Primary Outcomes (1)

• 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. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking pain medication. The mean of these pain ratings will be the primary outcome measure. The Wong-Baker FACES scale is from 0 (min) to 10 (max). A higher score indicates worse outcome/pain.

  14 days post-operatively

Secondary Outcomes (2)

• Number of Participants With ED (Emergency Department) or Urgent Care Visits

  14 days post-operatively

• Number of Side Effects of Medications

  14 days post-operatively

Other Outcomes (11)

• Number of Participants With Readmissions

  14 days post-operatively

• Average Dose of Each Analgesic Used

  14 days post-operatively

• Duration of Each Analgesic Used

  14 days post-operatively

Study Arms (2)

Opioid pain control

EXPERIMENTAL

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.

Drug: Oxycodone; Drug: Ibuprofen; Drug: Acetaminophen

Non-opioid pain control

ACTIVE COMPARATOR

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.

Drug: Ibuprofen; Drug: Acetaminophen

Interventions

Oxycodone DRUG

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.

Opioid pain control

Ibuprofen DRUG

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.

Non-opioid pain control; Opioid pain control

Acetaminophen DRUG

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; Opioid pain control

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients age 3 - 17 undergoing adenotonsillectomy

You may not qualify if:

• Down syndrome
• 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

Sponsors & Collaborators

• David Chi, MD: lead

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (11)

• 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.

  PMID: 28802595 BACKGROUND

• 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.

  PMID: 28033313 BACKGROUND

• 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.

  PMID: 28687823 BACKGROUND

• 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.

  PMID: 29215370 BACKGROUND

• 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.

  PMID: 29189368 BACKGROUND

• Holte K, Kehlet H. Effect of postoperative epidural analgesia on surgical outcome. Minerva Anestesiol. 2002 Apr;68(4):157-61.

  PMID: 12024074 BACKGROUND

• 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.

  PMID: 29135493 BACKGROUND

• 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.

  PMID: 17903568 BACKGROUND

• 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.

  PMID: 26884362 BACKGROUND

• 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.

  PMID: 25624387 BACKGROUND

• 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.

  PMID: 40396501 DERIVED

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Oxycodone; Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Limitations and Caveats

Early termination due to COVID-19 cases and cancelled surgeries.

Results Point of Contact

• Title: Senior Research Associate
• Organization: UPMC Children's Hospital of Pittsbugh

nelsonjl2@upmc.edu

1412-692-9879

Study Officials

• David H Chi, MD

  Clinical Director, Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Experimental, open-label randomized control trial.

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 7, 2018
• Study Start: October 25, 2018
• Primary Completion: May 18, 2020
• Study Completion: May 18, 2020
• Last Updated: November 10, 2021
• Results First Posted: November 10, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: All data will be maintained for at least 7 years or until the child turns 23 per University of Pittsburgh policy.
• Access Criteria: All data will be shared as-needed for analysis amongst the listed co-investigators in the University of Pittsburgh IRB protocol for this study. It will be stored on the UPMC OneDrive.

Locations

US (1)