About 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patients 2-18 years of age
Weighing greater than 10 kg
Undergoing adenotonsillectomy
English- or Spanish-speaking patients
Disqualifiers
Any adjunct procedure other than bilateral myringotomy tubes (BMT) or direct laryngoscopy and bronchoscopy (DLB) without bronchoalveolar lavage (BAL)
Bleeding disorders
Allergy to NSAIDs
Allergy to acetaminophen (Tylenol)
Trial design
Parallel
Treatments tested in this trial
Celecoxib
DrugOral celecoxib 6 mg/kg per dose (max 100 mg), given the evening before surgery and the morning of surgery
Acetaminophen
DrugIntra-operative acetaminophen (Tylenol)
Dexamethasone
DrugIntra-operative dexamethasone (Decadron)
Treatment groups
Trial outcomes
Primary outcomes
Rescue Analgesic Use in PACU
Chart-verified rescue analgesic consumption in the post-anesthesia care unit (PACU), expressed in morphine equivalents (PO/IV).
Time to First Rescue Analgesic in PACU
Time to first chart-verified rescue analgesic consumption in the post-anesthesia care unit (PACU).
Rescue Opioid Analgesic Use within 72 Hours Post-Op
Rescue opioid analgesic consumption, expressed in morphine equivalents (PO/IV), within 72 hours after surgery.
Time to First Rescue Opioid Analgesic Use within 72 Hours Post-Op
Time to first rescue escue opioid analgesic consumption within 72 hours after surgery.
Secondary outcomes
PACU Length of Stay
Post-Operative PACU Pain Score: Wong-Baker
Post-operative pain will be assessed in the PACU using the Wong-Baker FACES pain rating scale. The scale asks participants to rate their pain on a scale from 0-10, with higher scores representing greater pain.
Return to normal diet
Time from surgery to resumption of normal oral intake, as recorded in patient/family diary.
Return to normal activity
Time from surgery to resumption of normal activity, as recorded in patient/family diary.
Sponsors and contacts
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