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Non-opioids for Analgesia After Adenotonsillectomy in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03618823
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
David Chi, MD, University of Pittsburgh

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.


Condition or disease Intervention/treatment Phase
Adenotonsillectomy Post-operative Analgesia Opioid Use Drug: Oxycodone Drug: Ibuprofen Drug: Acetaminophen Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental, open-label randomized control trial.
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Non-Opioid Pain Medications After Adenotonsillectomy
Actual Study Start Date : October 25, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: 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.

Drug: 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.

Drug: 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.

Active Comparator: 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.
Drug: 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.

Drug: 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.




Primary Outcome Measures :
  1. Average pain burden [ Time Frame: 14 days post-operatively ]
    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.


Secondary Outcome Measures :
  1. ED (Emergency Department) or urgent care visits [ Time Frame: 14 days post-operatively ]
    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.

  2. Side effects of medications [ Time Frame: 14 days post-operatively ]
    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.


Other Outcome Measures:
  1. Number of readmissions [ Time Frame: 14 days post-operatively ]
    Number of hospitalizations after discharge in 14 days - assessed using the electronic medical record and the take-home pain diary.

  2. Average dose of each analgesic used [ Time Frame: 14 days post-operatively ]
    In the take-home pain diary, patients will record the amount of medication taken for each dose. The mean value of these doses will be calculated and averaged within each group to determine the average dose of each analgesic used.

  3. Duration of each analgesic used [ Time Frame: 14 days post-operatively ]
    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.

  4. Mean of total quantity of pain medications taken [ Time Frame: 14 days post-operatively ]
    Using the take-home pain diary, the total amount in mL of each analgesic used over 14 days by each patient in a group will be averaged and reported.

  5. Overall pain relief satisfaction [ Time Frame: 14 days post-operatively ]
    Score assigned by the patient at the end of 14 post-operative days in the take-home pain diary using a Likert scale. 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.

  6. Post-operative nursing phone calls [ Time Frame: 14 days post-operatively ]
    Number of post-operative phone calls to nursing staff, obtained using the electronic medical record.

  7. Night-time awakenings [ Time Frame: 14 days post-operatively ]
    Number of night-time awakenings reported in 14 days - assessed via the take-home pain diary.

  8. Non-opioid group switching to opioid group [ Time Frame: 14 days post-operatively ]
    Number of non-opioid group members switching to receiving opioid medication - assessed via the take-home pain diary.

  9. Need for follow-up appointment [ Time Frame: two months post-operatively ]
    Does the parent/guardian believe his/her child would require a follow-up appointment - assessed using the individual pain diary.

  10. Household income [ Time Frame: 14 days post-operatively ]
    Total household income ranges will be assessed in the take-home pain diary and reported.

  11. Education level [ Time Frame: 14 days post-operatively ]
    Using the take-home pain diary, parents/guardians of the patients will identify the highest level of education achieved by anyone in the household.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• Patients age 3 - 17 undergoing adenotonsillectomy

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618823


Contacts
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Contact: Jennifer McCoy, MA 4126929879 nelsonjl2@upmc.edu
Contact: Amber Shaffer, PhD 4126926874 shafferad@upmc.edu

Locations
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United States, Pennsylvania
UPMC Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Jennifer McCoy, MA    412-692-9879    nelsonjl2@upmc.edu   
Contact: Amber Shaffer, PhD    412-692-6874    shafferad@upmc.edu   
Sponsors and Collaborators
David Chi, MD
Investigators
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Principal Investigator: David H Chi, MD Clinical Director, Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh
Publications:

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Responsible Party: David Chi, MD, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03618823    
Other Study ID Numbers: STUDY19040036
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Only co-investigators as listed under the University of Pittsburgh IRB (Institutional Review Board) protocol for this study will have access to all data and analysis. Data will be shared via UPMC-associated OneDrive and will only be shared between these investigators.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by David Chi, MD, University of Pittsburgh:
analgesia
pain control
adenotonsillectomy
tonsillectomy
opioids
post-operative pain
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Acetaminophen
Ibuprofen
Oxycodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants