NCT04879823

Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity

Terminated Phase 3 Results posted Last updated 5 September 2024

What this trial tests

Phase 3 trial testing Dexamethasone in Adenotonsillectomy in 222 participants. Terminated before completion.

Timeline

5 August 2021

Primary endpoint
11 July 2023

11 July 2023

Quick facts

Lead sponsor	David Chi, MD
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	222
Start date	5 August 2021
Primary completion	11 July 2023
Estimated completion	11 July 2023
Sites	2 locations across United States

Drugs / interventions tested

• Dexamethasone (dexamethasone) — full drug profile →
• Ibuprofen (ibuprofen) — full drug profile →
• Acetaminophen (Paracetamol) — full drug profile →
• Placebo

Conditions studied

• Adenotonsillectomy — all drugs for Adenotonsillectomy →
• Analgesia — all drugs for Analgesia →
• Surgery — all drugs for Surgery →

Sponsor

David Chi, MD

Who can join

Adults 3 to 17, any sex, with Adenotonsillectomy or Analgesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Pain Over 2-8 Post-operative Days Before Medications Primary · 2-8 days post-operatively

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.

Group	Value	95% CI
Dexamethasone	4.2	3.7 – 4.7
Placebo	4.9	4.4 – 5.4

ED (Emergency Department) or Urgent Care Visits Secondary · 30 days post-operatively

Number of emergency department or urgent care visits in 30 post-operative days - assessed via the electronic medical record and the take-home pain diary.

Group	Value	95% CI
Dexamethasone	97
Placebo	91
Dexamethasone	5
Placebo	14
Dexamethasone	3
Placebo	2
Dexamethasone	0
Placebo	1

Average Pain Burden Post-medication Secondary · 2-8 days post-operatively

Average pain over 2-8 post-operative days after 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 one hour after talking pain medications from post-operative days 2-8 will be a secondary outcome measure.

Group	Value	95% CI
Dexamethasone	2.3	0.0 – 8.0
Placebo	2.2	0.0 – 7.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 5-9 weeks depending on the date of the follow-up appointment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dexamethasone

Serious: 3/105 (3%)

Deaths: 0/105

Placebo

Serious: 8/108 (7%)

Deaths: 0/108

Serious adverse events (3 terms)

Reaction	System	Dexamethasone	Placebo
Post-Tonsillectomy Hemorrhage with Inpatient Admission but Not Requiring Operative Intervention	Injury, poisoning and procedural complications	—	—
Post-Tonsillectomy Hemorrhage Requiring Operative Intervention	Injury, poisoning and procedural complications	—	—
Dehydration Requiring Inpatient Admission	Metabolism and nutrition disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Dexamethasone	Placebo
Emergency Department Visit for Post-Operative Pain	General disorders	—	—
Emergency Department Visit for Post-Operative Nausea or Vomiting	Gastrointestinal disorders	—	—
Post-Tonsillectomy Hemorrhage Requiring Neither Operative Intervention nor Inpatient Admission	Injury, poisoning and procedural complications	—	—
Surgical Site Infection	Infections and infestations	—	—

Most-reported serious reactions: Post-Tonsillectomy Hemorrhage with Inpatient Admission but Not Requiring Operative Intervention, Post-Tonsillectomy Hemorrhage Requiring Operative Intervention, Dehydration Requiring Inpatient Admission.

Data from ClinicalTrials.gov NCT04879823 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.