Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity

NCT04879823 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: STUDY20120036
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 2

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.

Conditions

Adenotonsillectomy; Analgesia; Surgery

Keywords

Pediatric Otolaryngology; Steroid; Placebo; Post-operative pain

Outcome Measures

Primary Outcomes (1)

• Average Pain Over 2-8 Post-operative Days Before Medications

  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 Outcomes (2)

• ED (Emergency Department) or Urgent Care Visits

  30 days post-operatively

• Average Pain Burden Post-medication

  2-8 days post-operatively

Other Outcomes (13)

• Number of Readmissions

  30 days post-operatively

• Frequency of Each Analgesic Used

  14 days post-operatively

• Duration of Each Analgesic Used

  14 days post-operatively

Study Arms (2)

Dexamethasone

EXPERIMENTAL

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; Drug: Acetaminophen

Placebo

PLACEBO COMPARATOR

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

Interventions

Dexamethasone DRUG

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

Dexamethasone

Ibuprofen DRUG

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.

Dexamethasone; Placebo

Acetaminophen DRUG

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.

Dexamethasone; Placebo

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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

Sponsors & Collaborators

• David Chi, MD: lead

Study Sites (2)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Children's Hospital North Surgery Center

Sewickley, Pennsylvania, 15143, United States

Location

Related Publications (11)

• 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.

  PMID: 23392233 BACKGROUND

• 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.

  PMID: 30585626 BACKGROUND

• 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.

  PMID: 31377901 BACKGROUND

• 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.

  PMID: 30448929 BACKGROUND

• 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.

  PMID: 22585378 BACKGROUND

• 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.

  PMID: 29573428 BACKGROUND

• 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.

  PMID: 33228459 BACKGROUND

• 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.

  PMID: 20003121 BACKGROUND

• 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.

  PMID: 11129008 BACKGROUND

• 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.

  PMID: 29215370 BACKGROUND

• 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.

  PMID: 29189368 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Dexamethasone; Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Limitations and Caveats

Early termination due to slow recruitment in older cohorts (8-12 and 13-17-year-olds) leading to small numbers of subjects analyzed in those age groups.

Results Point of Contact

• Title: Dr. Amber Shaffer
• Organization: UPMC Children's Hospital of Pittsburgh

shafferad@upmc.edu

4126926874

Study Officials

• David H. Chi, MD

  Clinical Director, Division of Pediatric Otolaryngology, UPMC Children's Hospital of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double blind placebo controlled randomized clinical trial

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 10, 2021
• Study Start: August 5, 2021
• Primary Completion: July 11, 2023
• Study Completion: July 11, 2023
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)