Preoperative Celecoxib and Acetaminophen Versus Acetaminophen Alone for Pain Control After Pediatric Adenotonsillectomy

Conditions

• Adenotonsillectomy
• Postoperative Pain

Eligibility Criteria

Sex

ALL

Age

2 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Celecoxib — DRUG
  Oral celecoxib 6 mg/kg per dose (max 100 mg), given the evening before surgery and the morning of surgery
• Acetaminophen — DRUG
  Intra-operative acetaminophen (Tylenol)
• Dexamethasone — DRUG
  Intra-operative dexamethasone (Decadron)

Study Details

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).

Key Dates

First listed

Oct 13, 2026

Start date

Nov 1, 2026

Status verified

Oct 2026

Primary completion

Aug 30, 2028

Completion

Dec 30, 2029

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pre-operative Celecoxib
  Pediatric patients (2-18 years, \>10 kg) undergoing adenotonsillectomy who receive oral celecoxib (6 mg/kg, max 100 mg) the evening before surgery and the morning of surgery, plus intra-operative dexamethasone (Decadron) and acetaminophen (Tylenol). Post-operative regimen is the attending's standard of care.
• Active Comparator: No pre-operative medication
  Pediatric patients (2-18 years, \>10 kg) undergoing adenotonsillectomy who receive no pre-operative medication; intra-operative dexamethasone (Decadron) and acetaminophen (Tylenol) only. Post-operative regimen is the attending's standard of care.

Primary Outcome Measure

Rescue Analgesic Use in PACU [ Time Frame: PACU Stay (PACU arrival to PACU discharge) - Approximately 3 Hours ]

Central Contacts

• Zahrah Taufique, MD
  646-501-7890
  [email protected]
• Jamie Schlacter, MD
  224-545-9048
  [email protected]

Locations (1)

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