NCT07672418Recruiting

Postoperative Pain After Pediatric Adenotonsillectomy With Ketorolac or Ibuprofen

Baylor College of Medicine

Start Date

6/24/2026

Completion Date

6/30/2028

Summary

This prospective observational study will evaluate postoperative pain after outpatient pediatric adenotonsillectomy in adolescents prescribed either acetaminophen with ibuprofen or acetaminophen with oral ketorolac after discharge, based on the prescribing preference of the otolaryngology surgeon. Participants will complete text-message surveys after discharge to assess pain severity, medication administration, and functional recovery for up to 14 days.

Detailed Description

Adenotonsillectomy is commonly associated with significant postoperative pain lasting 10-14 days. As opioid prescribing after adenotonsillectomy has decreased, non-opioid regimens using acetaminophen with either ibuprofen or ketorolac are increasingly used. However, post-discharge pain outcomes with oral ketorolac are not well described. This study will compare postoperative pain experience, severe pain incidence, medication use, functional recovery, and healthcare utilization after discharge among patients receiving acetaminophen plus ibuprofen versus acetaminophen plus low-dose oral ketorolac as part of routine care.

Eligibility Criteria

Age Range: 13 years to 18 years

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

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

SleepPediatricsAdenotonsillectomy

Locations

Baylor College of Medicine/ Texas Childrens Hospital

Houston, Texas 77030

United States