- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04879823
Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Jennifer L. McCoy, MA
- Phone Number: 412-692-9879
- Email: mccoyJL@upmc.edu
Study Contact Backup
- Name: Amber D. Shaffer, PhD.
- Phone Number: 412-692-6874
- Email: shafferad@upmc.edu
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: David H. Chi, MD, Clinical Director, Division of Pediatric Otolaryngology, UPMC Children's Hospital of Pittsburgh
Publications and helpful links
General Publications
- 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.
- Garra G, Singer AJ, Taira BR, Chohan J, Cardoz H, Chisena E, Thode HC Jr. Validation of the Wong-Baker FACES Pain Rating Scale in pediatric emergency department patients. Acad Emerg Med. 2010 Jan;17(1):50-4. doi: 10.1111/j.1553-2712.2009.00620.x. Epub 2009 Dec 9.
- Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
- Whelan RL, McCoy J, Mirson L, Chi DH. Opioid prescription and postoperative outcomes in pediatric patients. Laryngoscope. 2019 Jun;129(6):1477-1481. doi: 10.1002/lary.27614. Epub 2018 Dec 26.
- Borgstrom A, Nerfeldt P, Friberg D. Postoperative pain and bleeding after adenotonsillectomy versus adenotonsillotomy in pediatric obstructive sleep apnea: an RCT. Eur Arch Otorhinolaryngol. 2019 Nov;276(11):3231-3238. doi: 10.1007/s00405-019-05571-w. Epub 2019 Aug 3.
- Titirungruang C, Seresirikachorn K, Kasemsuwan P, Hirunwiwatkul P. The use of steroids to reduce complications after tonsillectomy: a systematic review and meta-analysis of randomized controlled studies. Eur Arch Otorhinolaryngol. 2019 Feb;276(2):585-604. doi: 10.1007/s00405-018-5202-2. Epub 2018 Nov 17.
- Macassey E, Dawes P, Taylor B, Gray A. The effect of a postoperative course of oral prednisone on postoperative morbidity following childhood tonsillectomy. Otolaryngol Head Neck Surg. 2012 Sep;147(3):551-6. doi: 10.1177/0194599812447776. Epub 2012 May 14.
- Redmann AJ, Maksimoski M, Brumbaugh C, Ishman SL. The effect of postoperative steroids on post-tonsillectomy pain and need for postoperative physician contact. Laryngoscope. 2018 Sep;128(9):2187-2192. doi: 10.1002/lary.27167. Epub 2018 Mar 24.
- Greenwell AG, Isaiah A, Pereira KD. Recovery After Adenotonsillectomy-Do Steroids Help? Outcomes From a Randomized Controlled Trial. Otolaryngol Head Neck Surg. 2021 Jul;165(1):83-88. doi: 10.1177/0194599820973250. Epub 2020 Nov 24.
- Palme CE, Tomasevic P, Pohl DV. Evaluating the effects of oral prednisolone on recovery after tonsillectomy: a prospective, double-blind, randomized trial. Laryngoscope. 2000 Dec;110(12):2000-4. doi: 10.1097/00005537-200012000-00003.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
- Acetaminophen
- Ibuprofen
Other Study ID Numbers
- STUDY20120036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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