Dexamethasone for Tonsillitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Tonsillitis+1 MoreDexamethasone - Drug
Eligibility
3 - 12
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Tonsillitis
  • Obstructive Sleep Apnea in Children

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Postoperative day 30

Postoperative day 30
Rate of 30-Day Emergency Room Visits
Rate of 30-Day Readmission
Rate of Postoperative Oropharyngeal Hemorrhage
Postoperative day 6
Diet and Activity Levels
Mean NSAID and Acetaminophen Consumption
Mean Opioid Consumption
Mean Visual Analog Score of Pain
Rate of Nausea and Vomiting

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Ondansetron
2%Cerebrospinal fluid leak
2%Deep Vein Thrombosis
2%Fever
This histogram enumerates side effects from a completed 2013 Phase 4 trial (NCT01474915) in the Ondansetron ARM group. Side effects include: Cerebrospinal fluid leak with 2%, Deep Vein Thrombosis with 2%, Fever with 2%.

Trial Design

2 Treatment Groups

No Steroid Group
1 of 2
Steroid Group
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Dexamethasone · No Placebo Group · Phase 2

Steroid Group
Drug
Experimental Group · 1 Intervention: Dexamethasone · Intervention Types: Drug
No Steroid GroupNoIntervention Group · 1 Intervention: No Steroid Group · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: postoperative day 30

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
838 Previous Clinical Trials
5,378,418 Total Patients Enrolled
Clarice S Clemmens, MDPrincipal InvestigatorMedical University of South Carolina

Eligibility Criteria

Age 3 - 12 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of Tonsillectomy with or without adenoidectomy for any indication.
References