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Oral Steroids for Post-Tonsillectomy Recovery

Phase 3

Waitlist Available

Led By David H. Chi, MD

Research Sponsored by David Chi, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two months post-operatively

Awards & highlights

Study Summary

This trial will test if oral steroids are a safe and effective way to lower pain and complications after adenotonsillectomy in children of various ages.

Who is the study for?

This trial is for children aged 3-17 who are undergoing adenotonsillectomy. It's not suitable for kids with bleeding disorders, diabetes, chronic opioid use, or allergies to study drugs. Also excluded are those on steroids or opioids during the study period and those unable to communicate pain due to conditions like Down syndrome.Check my eligibility

What is being tested?

The trial is testing if dexamethasone can reduce pain and complications after tonsil surgery in kids compared to a placebo. This double-blind study means neither the doctors nor participants know who gets the real drug or placebo until it's over.See study design

What are the potential side effects?

Dexamethasone may cause side effects such as increased appetite, mood changes, stomach upset, and potential risk of infection. Acetaminophen could lead to liver issues at high doses; ibuprofen might cause stomach discomfort or kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two months post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two months post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and two months post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average pain burden pre-medication

Secondary outcome measures

Average pain burden post-medication

ED (Emergency Department) or urgent care visits

Other outcome measures

Duration of each analgesic used

Duration of hospital admission

Education level

+10 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DexamethasoneExperimental Treatment3 Interventions

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.

Group II: PlaceboPlacebo Group3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetaminophen

2017

Completed Phase 4

~2030

Dexamethasone

2007

Completed Phase 4

~2590

Ibuprofen

2013

Completed Phase 4

~5800

Do I qualify?Apply below to find out

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Who is running the clinical trial?

David Chi, MDLead Sponsor

3 Previous Clinical Trials

726 Total Patients Enrolled

2 Trials studying Adenotonsillectomy

340 Patients Enrolled for Adenotonsillectomy

David H. Chi, MDPrincipal InvestigatorClinical Director, Division of Pediatric Otolaryngology, UPMC Children's Hospital of Pittsburgh

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04879823 — Phase 3

Adenotonsillectomy Research Study Groups: Dexamethasone, Placebo

Adenotonsillectomy Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04879823 — Phase 3

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04879823 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will this experimental treatment be available to patients over the age of 35?

"This trial includes children that are aged 3-17, as per the inclusion criteria listed."

Answered by AI

Who might this clinical trial be able to help the most?

"Analgesia trials such as this one are looking for 300 individuals that fit the age criteria of being between 3 and 17 years old. Other requirements for potential participants include: those patients who will be undergoing adenotonsillectomy."

Answered by AI

Are people still signing up for this experiment?

"Yes, the clinical trial is currently recruiting patients according to the most recent data from clinicaltrials.gov. The posting went up on 8/5/2021 and was last updated on 3/4/2022. They are hoping to enroll 300 people at 2 sites."

Answered by AI

For what medical conditions is Dexamethasone prescribed?

"Dexamethasone is a medication typically used to combat synovitis. However, it has also shown therapeutic potential for managing branch retinal vein occlusion, whiplash syndrome, ophthalmia, and sympathetic conditions."

Answered by AI

How many individuals are being monitored in this experiment?

"That is correct. The clinicaltrials.gov website suggests that this trial, which was first posted on 8/5/2021, is still looking for participants. They study needs to recruit 300 patients from 2 different sites."

Answered by AI