Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity

Sponsor

David Chi, MD (Other)

Overall Status

Recruiting

CT.gov ID

NCT04879823

Collaborator

(none)

300

Enrollment

Locations

Arms

33.9

Anticipated Duration (Months)

150

Patients Per Site

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Adenotonsillectomy Analgesia Surgery	Drug: Dexamethasone Drug: Ibuprofen Drug: Acetaminophen Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double blind placebo controlled randomized clinical trialDouble blind placebo controlled randomized clinical trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity

Actual Study Start Date :

Aug 5, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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.	Drug: 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 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.
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.	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. Drug: 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.

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.

Drug: Dexamethasone

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.

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.

Drug: Ibuprofen

Drug: Acetaminophen

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Average pain burden [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. 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.

Secondary Outcome Measures

ED (Emergency Department) or urgent care visits [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.

Other Outcome Measures

Number of readmissions [30 days post-operatively]
Number of hospitalizations after discharge in 30 days - assessed using the electronic medical record and the take-home pain diary.
Frequency of each analgesic used [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.
Duration of each analgesic used [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.
Pain relief satisfaction [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.
Frequency of request for opioid medication [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.
Frequency of post-operative oropharyngeal bleed [30 days post-operatively]
Number of post-operative oropharyngeal bleeds in 30 post-operative days - assessed via the electronic medical record.
Need for follow-up appointment [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 [14 days post-operatively]
Total household income ranges will be assessed in the take-home pain diary and reported.
Education level [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.
Side effects of medications [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)
Night-time awakenings [14 days post-operatively]
Number of night-time awakenings reported in 14 days - assessed via the take-home pain diary.
Post-operative nursing phone calls [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.
Duration of hospital admission [30 days post-operatively]
Number of days in the hospital after surgery in 30 post-operative days - assessed via the electronic medical record

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15224
2	Children's Hospital North Surgery Center	Sewickley	Pennsylvania	United States	15143