Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity

January 12, 2024 updated by: David Chi, MD
The goal of this study is determine if an oral systemic course of steroids is a safe and effective option in lowering pain and complications following adenotonsillectomy in various pediatric age groups. A double blind, placebo-controlled randomized clinical trial of steroids (dexamethasone) versus placebo postoperatively will be performed. Investigators will determine if there is a difference in post-operative pain and complications between groups.

Study Overview

Detailed Description

Purpose: To determine if post-operative dexamethasone is a safe and effective option in the reduction of post-operative pain and morbidity 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 double-blinded arms - patients receiving a course of oral dexamethasone (doses on post-operative days 2, 4, and 6; 0.5 mg/kg; max dose: 20 mg) in addition to standard pain control regimen and patients receiving an oral placebo course in addition to standard pain control regimen. In the diary they will receive, patients or caregivers will record when specific pain medications were taken each day, a symptoms survey, and pain ratings measured by the Wong-Baker FACES Pain Rating Scale. Patients are able to return their diary at a post-operative appointment at CHP Main, through email by scanning the diary or taking pictures with their phone, or through mailing in the survey in a pre-stamped envelope. Demographic information such as age, race, gender, and 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 dexamethasone after adenotonsillectomy can reduce pain, complications, or need for opioid analgesics without appreciable side effects, a strong argument can be made for the addition of this inexpensive medication to routine post-operative adenotonsillectomy care. This would help with limiting the burden of clinical course of tonsillectomy.

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jennifer L. McCoy, MA
  • Phone Number: 412-692-9879
  • Email: mccoyJL@upmc.edu

Study Contact Backup

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • UPMC Children's Hospital of Pittsburgh
      • Sewickley, Pennsylvania, United States, 15143
        • Children's Hospital North Surgery Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients age 3 - 17 undergoing adenotonsillectomy meet inclusion criteria

Exclusion Criteria:

  • Patients with Down syndrome
  • Patients with a history of coagulopathy
  • Patients with craniofacial abnormalities other than plagiocephaly or submucous cleft palate (SMCP)
  • Caregivers who cannot speak, read, or write in English proficiently
  • Patients who take systemic corticosteroids during the enrollment period
  • Patients who take opioids during the enrollment period
  • Patients who take chronic opioids
  • Patients who are pregnant
  • Patients with 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
  • Patients who have type 1 diabetes
  • Patients who have type 2 diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone

IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup.

Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days.

Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.

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 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.
IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup
Placebo Comparator: Placebo

An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup.

Patients will also receive acetaminophen and ibuprofen. Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days.

Patients and parents/caregivers will be asked to complete a pain diary which will be used to determine the level of pain control achieved with this regimen. Families will also be asked daily to check symptoms that were experienced by the child and their child's current comfortable diet. The diary will be completed by post-operative day 14. The diary will be returned via email, mail, or a post-operative appointment at the main hospital.

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 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.
An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average pain burden pre-medication
Time Frame: 2-8 days post-operatively
Average pain over 2-8 post-operative days before 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 the pain ratings prior to taking pain medications from post-operative days 2-8 will be the primary outcome measure.
2-8 days post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ED (Emergency Department) or urgent care visits
Time Frame: 30 days post-operatively
Number of emergency department or urgent care visits in 30 post-operative days - assessed via the electronic medical record and the take-home pain diary.
30 days post-operatively
Average pain burden post-medication
Time Frame: 2-8 days post-operatively
Average pain over 2-8 post-operative days 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 the pain ratings one hour after talking pain medications from post-operative days 2-8 will be a secondary outcome measure.
2-8 days post-operatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of each analgesic used
Time Frame: 14 days post-operatively
In the take-home pain diary, patients will place an 'x' on each time block every day that medication was given for each of the three medications. The frequencies will be summed for a total number and averaged within each group to determine the average number of times of each analgesic used.
14 days post-operatively
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 5-point Likert scale of 0 (strongly disagree) to 4 (strongly agree). 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. Higher scores indicate a better outcome.
14 days post-operatively
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.
14 days post-operatively
Household income
Time Frame: 14 days post-operatively
Total household income ranges will be assessed in the take-home pain diary and reported.
14 days post-operatively
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.
14 days post-operatively
Number of readmissions
Time Frame: 30 days post-operatively
Number of hospitalizations after discharge in 30 days - assessed using the electronic medical record and the take-home pain diary.
30 days post-operatively
Duration of each analgesic used
Time Frame: 14 days post-operatively
Using the results of the take-home pain diary, the average number of days of use of each analgesic for each group will be calculated. The last day after which there is no subsequent use of analgesic will define the end-point of the duration of use.
14 days post-operatively
Frequency of request for opioid medication
Time Frame: 14 days post-operatively
Number of requests for opioid medication in 14 post-operative days - assessed via the electronic medical record and the take-home pain diary.
14 days post-operatively
Frequency of post-operative oropharyngeal bleed
Time Frame: 30 days post-operatively
Number of post-operative oropharyngeal bleeds in 30 post-operative days - assessed via the electronic medical record.
30 days post-operatively
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.
Two months post-operatively
Side effects of medications
Time Frame: 14 days post-operatively
Number of side effects assessed daily including bleeding from mouth or throat, anxiety, difficulty breathing, nausea or vomiting, stomach pain/discomfort, fever (100.4F and higher)
14 days post-operatively
Post-operative nursing phone calls
Time Frame: 30 days post-operatively
Number of post-operative phone calls to nursing staff, obtained using the electronic medical record up to 30 days post-operatively.
30 days post-operatively
Duration of hospital admission
Time Frame: 30 days post-operatively
Number of days in the hospital after surgery in 30 post-operative days - assessed via the electronic medical record
30 days post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: David H. Chi, MD, Clinical Director, Division of Pediatric Otolaryngology, UPMC Children's Hospital of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2021

Primary Completion (Actual)

July 11, 2023

Study Completion (Actual)

July 11, 2023

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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