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Non-opioids for Analgesia After Adenotonsillectomy in Children

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ClinicalTrials.gov Identifier: NCT03618823
Recruitment Status : Active, not recruiting
First Posted : August 7, 2018
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
David Chi, MD, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE August 1, 2018
First Posted Date  ICMJE August 7, 2018
Last Update Posted Date March 5, 2021
Actual Study Start Date  ICMJE October 25, 2018
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 1, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Household income [ Time Frame: 14 days post-operatively ]
    Total household income ranges will be assessed in the take-home pain diary and reported.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Non-opioids for Analgesia After Adenotonsillectomy in Children
Official Title  ICMJE Randomized Clinical Trial of Non-Opioid Pain Medications After Adenotonsillectomy
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Adenotonsillectomy
  • Post-operative Analgesia
  • Opioid Use
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Oxycodone
    • Drug: Ibuprofen
    • Drug: Acetaminophen
  • 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.
    Interventions:
    • Drug: Ibuprofen
    • Drug: Acetaminophen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 3, 2021)
268
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2018)
300
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03618823
Other Study ID Numbers  ICMJE STUDY19040036 (Part 1)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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.
Responsible Party David Chi, MD, University of Pittsburgh
Study Sponsor  ICMJE David Chi, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David H Chi, MD Clinical Director, Division of Pediatric Otolaryngology, Children's Hospital of Pittsburgh
PRS Account University of Pittsburgh
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP