Celecoxib + Acetaminophen for Postoperative Pain

JS
ZT
Overseen ByZahrah Taufique, MD
Age: < 65
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is an open-label randomized study of approximately 500 pediatric patients (2-18 years of age, weighing more than 10 kg) undergoing adenotonsillectomy. Participants are assigned to a preoperative multimodal analgesic regimen (oral celecoxib the evening before and the morning of surgery, plus intra-operative dexamethasone and acetaminophen) or to standard of care (no pre-operative medication; intra-operative dexamethasone and acetaminophen). The primary aim is to compare postoperative pain control, measured by rescue analgesic consumption, over the first 72 hours after surgery. Secondary aims assess safety (postoperative bleeding and adverse medication events) and feasibility (healthcare utilization and caregiver satisfaction).

Who Is on the Research Team?

CY

Christina Yang, MD

Principal Investigator

NYU Langone Health

ZT

Zahrah Taufique, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for children aged 2 to 18 years, weighing over 10 kg, who are scheduled to have their tonsils and adenoids removed (adenotonsillectomy).

Inclusion Criteria

I am between 2 and 18 years old.
Weighing greater than 10 kg
English- or Spanish-speaking patients
See 1 more

Exclusion Criteria

I have not had any procedures except BMT or DLB without BAL.
Allergy to NSAIDs
Allergy to acetaminophen (Tylenol)
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Acetaminophen
  • Celecoxib
  • Dexamethasone

Trial Overview

The study compares giving celecoxib with acetaminophen before surgery versus just acetaminophen (both groups also get dexamethasone during surgery) to see which approach better controls pain after the operation.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Pre-operative CelecoxibExperimental Treatment3 Interventions
Group II: No pre-operative medicationActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+