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Corticosteroid

Steroids for Post-Tonsillectomy Pain

Phase 2

Recruiting

Led By Clarice S Clemmens, MD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

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

Must have

Age 3-12

Tonsillectomy with or without adenoidectomy for any indication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative day 30

Awards & highlights

Study Summary

This trial will test if taking a steroid pill after tonsillectomy reduces pain and the need for narcotic drugs.

Who is the study for?

This trial is for children aged 3-12 undergoing outpatient tonsillectomy, with or without adenoidectomy. It's not suitable for kids with bleeding disorders, recent steroid or opioid use, surgical complications, or if the guardian cannot be reached by phone.Check my eligibility

What is being tested?

The study tests whether a single oral dose of Dexamethasone can reduce pain and lessen the need for narcotic medications after tonsil surgery compared to a placebo.See study design

What are the potential side effects?

Dexamethasone may cause side effects such as sleep problems, increased appetite, mood changes, upset stomach, and potential increase in infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between the ages of 3 and 12.

Select...

I have had my tonsils removed, with or without adenoid removal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperative day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative day 30 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Mean Visual Analog Score of Pain

Secondary outcome measures

Diet and Activity Levels

Mean NSAID and Acetaminophen Consumption

Mean Opioid Consumption

+4 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: Steroid GroupExperimental Treatment1 Intervention

Participants will receive a one-time dose of oral dexamethasone at 0.5 mg/kg on the third post-operative day

Group II: No Steroid GroupPlacebo Group2 Interventions

Participants will receive placebo on third post-operative day

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,485 Total Patients Enrolled

Clarice S Clemmens, MDPrincipal InvestigatorMedical University of South Carolina

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03995628 — Phase 2

Tonsillitis Research Study Groups: Steroid Group, No Steroid Group

Tonsillitis Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT03995628 — Phase 2

Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03995628 — Phase 2

Frequently Asked Questions

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

Under what qualifications can participants join this experiment?

"This medical trial is currently welcoming 150 minors between the ages of 3 and 12 who have been diagnosed with tonsillitis. Patients must also fulfill two additional requirements to qualify: (1) age range of 3-12 years old, and (2) outpatient surgery."

Answered by AI

Is this trial open for enrolment at the moment?

"Yes, the information available on clinicaltrials.gov confirms that this medical trial is actively recruiting individuals for participation. Initially posted in December 18th 2018 and last revised on July 23rd 2022, it aims to recruit 150 patients from a single location."

Answered by AI

What is the aggregate figure for those taking part in this trial?

"Indeed, information on clinicaltrials.gov verifies that this clinical investigation is presently seeking volunteers. This study was first published on December 18th 2018 and the most recent update took place July 23rd 2022; 150 participants are needed from a single location."

Answered by AI

What is the current status of Dexamethasone with regards to authorization from the FDA?

"Since Dexamethasone has only been evaluated in a Phase 2 trial, meaning there is some confirmation of safety but no assurance of efficacy, our team at Power assigned it a score of 2 on the risk scale."

Answered by AI

Is Dexamethasone a familiar component of prior medical studies?

"Currently, the clinical landscape for Dexamethasone is quite extensive; 552 trials with 144 in Phase 3. While some of these studies are hosted in Joliet, Illinois, a total of 18606 sites across the world offer testing and treatment based on this drug."

Answered by AI

What medical conditions does Dexamethasone commonly treat?

"Customarily, dexamethasone is a remedy for ophthalmia or sympathetic. This drug can also be utilized to combat eye conditions such as branch retinal vein occlusion and macular edema."

Answered by AI

Is the age limitation for this trial restricted to those over 80 years old?

"This medical experiment has specified that participants must be within the age range of 3 to 12. Notably, there are 118 trials available for minors and 675 experiments targeting elderly people."

Answered by AI

Recent research and studies

The Open Nursing JournalJournal

Patients´ Experiences of Pain Following Day Surgery - at 48 Hours, Seven Days and Three Months

Rosén, Helena Inger, Ingrid Helena Bergh, Anders Odén, and Lena Birgitta Mårtensson. 2011. “Patients´ Experiences of Pain Following Day Surgery - at 48 Hours, Seven Days and Three Months”. The Open Nursing Journal. Bentham Science Publishers Ltd.. doi:10.2174/1874434601105010052.

TrialsJournal

Single Dose Oral Dexamethasone Versus Multi-dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in Children Who Attend the Emergency Department: Study Protocol for a Randomized Controlled Trial

Cronin, John, Una Kennedy, Siobhan McCoy, Sinéad Nic an Fhailí, Gloria Crispino-O’Connell, John Hayden, Abel Wakai, Sean Walsh, and Ronan O’Sullivan. 2012. “Single Dose Oral Dexamethasone Versus Multi-dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in Children Who Attend the Emergency Department: Study Protocol for a Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/1745-6215-13-141.

The LaryngoscopeJournal

The Effect of Postoperative Steroids on Post-tonsillectomy Pain and Need for Postoperative Physician Contact

Redmann, Andrew J., Matthew Maksimoski, Cheryl Brumbaugh, and Stacey L. Ishman. 2018. “The Effect of Postoperative Steroids on Post-tonsillectomy Pain and Need for Postoperative Physician Contact”. The Laryngoscope. Wiley. doi:10.1002/lary.27167.

PainJournal