Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy

NCT04791761 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: STUDY19040036 (Part 2)
• Study Type: interventional
• Target: 73
• 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 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.

Conditions

Adenotonsillectomy; Post-operative Analgesia; Opioid Use

Keywords

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

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. 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 Outcomes (1)

• ED (Emergency Department) or Urgent Care Visits

  14 days post-operatively

Other Outcomes (12)

• Number of Readmissions

  14 days post-operatively

• Frequency of Each Analgesic Used

  14 days post-operatively

• Duration of Each Analgesic Used

  14 days post-operatively

Study Arms (3)

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 or by email/mail if no appointment was scheduled. Families will receive an opioid disposal education document.

Drug: Oxycodone; Drug: Ibuprofen; Drug: Acetaminophen; Other: Opioid disposal education

Opioid pain control + Disposal Pouch

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 or by email/mail if no appointment was scheduled. Half of the families randomized to the opioid group will be further randomized to receive an opioid disposal bag + an opioid disposal education document. The pouch is a drug deactivation disposal pouch to dispose the opioid at home.

Drug: Oxycodone; Drug: Ibuprofen; Drug: Acetaminophen; Other: Opioid disposal pouch; Other: Opioid disposal education

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 or by email/mail if no appointment was scheduled.

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; Opioid pain control + Disposal Pouch

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; Opioid pain control + Disposal Pouch

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; Opioid pain control + Disposal Pouch

Opioid disposal pouch OTHER

Half of the opioid group will be randomized assigned to an opioid disposal pouch arm. This pouch is a drug deactivation system that can be disposed in the trash in a household.

Opioid pain control + Disposal Pouch

Opioid disposal education OTHER

An opioid disposal education document will be provided to all families in the opioid group. This education document has information on unused or expired prescription medication disposal and specific information about permanent collection sites within our health system, drug take-back locations, drug take back day, and disposing at home.

Opioid pain control; Opioid pain control + Disposal Pouch

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• 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 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

Sponsors & Collaborators

• David Chi, MD: lead

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (10)

• 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

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 slow recruitment leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Amber Shaffer
• Organization: UPMC Children's Hospital of Pittsburgh

shafferad@upmc.edu

4126926874

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

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: March 5, 2021
• First Posted: March 10, 2021
• Study Start: April 13, 2021
• Primary Completion: July 3, 2023
• Study Completion: July 3, 2023
• Last Updated: August 30, 2024
• Results First Posted: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)