Clinical trial Recruiting at 1 site Observational Ages 13 to 18

Postoperative Pain After Pediatric Adenotonsillectomy: Ibuprofen Plus Tylenol vs Ketorolac Plus Tylenol

Official title: Assessment of Postoperative Pain Outcomes Following Pediatric Adenotonsillectomy and the Impact on Non-Steroidal Anti-Inflammatory Drugs

Run by Baylor College of Medicine · NCT07672418 · Data updated 2026-11-12

This observational study will see if teens (13-18) who have adenotonsillectomy and take acetaminophen with ibuprofen or acetaminophen with ketorolac after discharge experience different levels of pain and recovery.

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Quick facts

Study typeObservational
Ages13 Years to 18 Years
SexAll
Enrollment200 (estimated)
SponsorBaylor College of Medicine
Academic / other
Locations1 site (Houston, Texas)
StatusRecruiting
StartedJune 24, 2026
Main results expectedJune 30, 2027
Study endsJune 30, 2028
Registry record updatedSeptember 8, 2026
Trial IDNCT07672418 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Teens aged 13-18 undergoing outpatient adenotonsillectomy, with access to text messaging and no exclusion criteria that would preclude non-opioid pain management per protocol.

Probably not a fit

Patients with contraindications to NSAIDs or acetaminophen or those needing opioids post-discharge may not benefit from the regimens studied.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study compares two non-opioid discharge regimens after outpatient pediatric adenotonsillectomy: acetaminophen with ibuprofen versus acetaminophen with low-dose oral ketorolac. Participants will report pain severity, medication use, and functional recovery via text messages for up to 14 days post-discharge. Outcomes include postoperative pain experiences, incidence of severe pain, healthcare utilization, and overall recovery as guided by routine care and surgeon preference. The study is conducted at Baylor College of Medicine and Texas Children’s Hospital in Houston, enrolling adolescents aged 13-18 without major comorbidities.

Why it matters

Potential benefit: If successful, the findings could help clarify which non-opioid regimen provides better pain control after adenotonsillectomy in teens.

How similar studies have gone: Non-opioid post-discharge regimens after adenotonsillectomy have shown varying efficacy; this study adds real-world data on ketorolac versus ibuprofen combinations.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Scheduled for outpatient adenotonsillectomy Age 13-18 years ASA physical status I-III Patient or parent has access to a phone with text-messaging capability Patient assent Parent or legal guardian consent

Exclusion Criteria:

Inpatient admission or planned 23-hour observation Known hematologic condition or prior bleeding disorder Current anticoagulant use Known or suspected chronic kidney disease or solitary kidney Known or suspected liver disease or prior liver transplant Known or suspected mitochondrial disease or genetic anomaly Inability to self-report pain History of gastrointestinal ulcer or bleeding Allergy to acetaminophen, ibuprofen, or ketorolac Non-English or non-Spanish speaking Chronic pain or condition requiring frequent routine NSAID use Patient refusal Parent or guardian refusal

Where it's running

  • Baylor College of Medicine/ Texas Childrens Hospital
    Houston, Texas, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.