Postoperative Pain After Pediatric Adenotonsillectomy With Ketorolac or Ibuprofen

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07672418

Enrollment

200

Registered

2026-06-29

Start date

2026-06-24

Completion date

2028-06-30

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenotonsillectomy, Pediatrics, Sleep

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

13 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of severe postoperative pain	Postoperative days 1, 3, 5, 7, 10	Pain score measured using the 0-10 Numeric Rating Scale after adenotonsillectomy.

Secondary

Measure	Time frame	Description
Incidence of severe postoperative pain	Postoperative days 1, 3, 5, 7, 10	Proportion of participants reporting severe pain, defined as Numeric Rating Scale score 7-10.

Countries

United States

Contacts

CONTACTAdam C Adler, MD

adam.adler@bcm.edu8328245800

Outcome results