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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age2-18
SponsorNYU Langone Health

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Pre-operative CelecoxibExperimental treatment 3 interventions
Group B: No pre-operative medicationActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Rescue Analgesic Use in PACU

Chart-verified rescue analgesic consumption in the post-anesthesia care unit (PACU), expressed in morphine equivalents (PO/IV).

Time frame
PACU Stay (PACU arrival to PACU discharge) - Approximately 3 Hours
2

Time to First Rescue Analgesic in PACU

Time to first chart-verified rescue analgesic consumption in the post-anesthesia care unit (PACU).

Time frame
PACU Stay (PACU arrival to PACU discharge) - Approximately 3 Hours
3

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 frame
Up to Hour 72 Post-Operation
4

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.

Time frame
Up to Hour 72 Post-Operation

Secondary outcomes

1

PACU Length of Stay

Time frame
PACU Stay (PACU arrival to PACU discharge) - Approximately 3 Hours
2

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.

Time frame
PACU Stay (PACU arrival to PACU discharge) - Approximately 3 Hours
3

Return to normal diet

Time from surgery to resumption of normal oral intake, as recorded in patient/family diary.

Time frame
Up to Hour 72 Post-Operation
4

Return to normal activity

Time from surgery to resumption of normal activity, as recorded in patient/family diary.

Time frame
Up to Hour 72 Post-Operation

Other outcomes

Sponsors and contacts

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