What is the mechanism of action of this treatment?

Steroids, such as fluticasone, are commonly used in the treatment of tonsillitis due to their potent anti-inflammatory properties. These medications work by reducing inflammation and swelling in the tonsils, which in turn alleviates pain and discomfort. This mechanism is crucial for tonsillitis patients as it not only helps in faster symptom relief but also minimizes the need for stronger pain medications, thereby reducing potential side effects and improving patient comfort during recovery.

What side effects are associated with this type of intervention?

Common treatments for tonsillitis, particularly steroids like fluticasone and mometasone, can have side effects including nausea, headache, fever, rash, and more severe reactions such as pancreatitis and pneumonitis. Topical application may cause local irritation or dryness. Intratonsillar steroid injections may lead to localized side effects such as tissue atrophy or infection.

What prior FDA approvals exist?

The FDA has approved various treatments for tonsillitis, primarily focusing on antibiotics to combat bacterial infections. However, for reducing pain and inflammation, corticosteroids like prednisone and dexamethasone are commonly used. These steroids are known for their anti-inflammatory properties, which help in reducing swelling and pain associated with tonsillitis. The study mentioned explores the use of a single oral dose of steroids post-tonsillectomy, which aligns with the broader use of corticosteroids in managing inflammation and pain in tonsillitis.

What other types of research exist?

Promising novel alternatives to steroids for tonsillitis treatment in 2024 may include: 1) Biologic agents such as anti-IL-17 or anti-IL-23 antibodies, which have shown efficacy in reducing inflammation in other conditions. 2) Non-steroidal anti-inflammatory drugs (NSAIDs) with improved safety profiles. 3) Topical antiseptics like povidone-iodine, which have been evaluated for their anti-inflammatory properties. 4) Novel small molecule inhibitors targeting specific inflammatory pathways. These alternatives should be discussed with a healthcare provider to determine the best treatment plan.

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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

Must not have

Pre-operative steroid use (defined as any steroid use greater than three days duration within 30 days prior to tonsillectomy)

Inability of parent/guardian to be contacted by phone for follow up

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative day 30

Awards & highlights

All Individual Drugs Already Approved

Approved for 60 Other Conditions

Summary

This trial is testing if an oral steroid called dexamethasone can reduce pain and the need for narcotic painkillers in children after tonsil removal surgery. Dexamethasone helps by reducing inflammation and swelling, which can make recovery less painful. It has been shown to be effective in reducing postoperative pain, swelling, and other complications in various surgeries, including third molar extractions and rhinoplasty.

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.

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.

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

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I am between the ages of 3 and 12.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used steroids for more than three days within a month before my tonsil surgery.

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My parent/guardian cannot be reached by phone for follow-ups.

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I cannot or do not want to give consent for the trial.

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I had complications during surgery or needed unexpected hospital stay.

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I have a bleeding disorder.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Visual Analog Score of Pain

Secondary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

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 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Steroids, such as fluticasone, are commonly used in the treatment of tonsillitis due to their potent anti-inflammatory properties. These medications work by reducing inflammation and swelling in the tonsils, which in turn alleviates pain and discomfort. This mechanism is crucial for tonsillitis patients as it not only helps in faster symptom relief but also minimizes the need for stronger pain medications, thereby reducing potential side effects and improving patient comfort during recovery.

Effect of intratonsillar injection of steroids on the palatine tonsils of rabbits.Salt chamber treatment is ineffective in treating eosinophilic inflammation in asthma.Corticosteroids for the common cold.