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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 13 Years to 18 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | June 24, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT07672418 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
- Study coordinator: Adam C Adler, MD
- Email: adam.adler@bcm.edu
- Phone: 8328245800
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Perfusion Index to Measure Postoperative Pain in Kids After Adenotonsillectomy
This study tests whether the perfusion index can reliably reflect pain levels in children aged 1–12 after adenotonsillectomy, comparing standard care with an added glossopharyngeal nerve block.
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Lactium premedication to see if it prevents emergence agitation after adenotonsillectomy
A preoperative dose of Lactium is tested to see if it prevents emergence agitation in children after adenotonsillectomy.
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Oral vs IV Magnesium for Emergence Delirium in Children after Adenotonsillectomy
This trial tests whether giving magnesium by mouth before surgery or by IV during surgery can reduce emergence delirium in children aged 4–7 undergoing adenotonsillectomy with sevoflurane anesthesia.
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Intranasal dexmedetomidine‑esketamine for pain relief after adenoid and tonsil surgery in children
This trial will test whether giving children aged 3–7 a combined dexmedetomidine and esketamine nasal dose reduces pain after adenoid and tonsil surgery.
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Ultrasound-guided glossopharyngeal and maxillary nerve blocks for pain control after adenotonsillectomy
Doctors will test whether adding ultrasound-guided glossopharyngeal and maxillary nerve blocks to usual pain control reduces pain after adenotonsillectomy in children aged 5–13.
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Oral melatonin versus nebulized dexmedetomidine to reduce emergence agitation after adenotonsillectomy in children
We will test whether giving oral melatonin or nebulized dexmedetomidine before anesthesia better prevents children aged 3–7 from becoming agitated as they wake after adenotonsillectomy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.