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NCT Number: NCT07672418

Postoperative Pain After Pediatric Adenotonsillectomy With Ketorolac or Ibuprofen

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor College of Medicine/ Texas Childrens Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of severe postoperative pain

    Time frame: Postoperative days 1-10

    Pain score measured using the 0-10 Numeric Rating Scale after adenotonsillectomy.

Secondary outcomes

  1. Incidence of severe postoperative pain

    Time frame: Postoperative days 1-10

    Proportion of participants reporting severe pain, defined as Numeric Rating Scale score 7-10.

Other outcomes

  1. Medication administration after discharge

    Time frame: Postoperative days 1-10

    Participant-reported completion, missed doses, or non-use of prescribed postoperative analgesics.

  2. Emergency department or urgent care visit for pain

    Time frame: Postoperative days 1-10

    Proportion of participants presenting to the emergency department or urgent care for pain related to adenotonsillectomy.

Study contacts

Contact information is provided by the study sponsor or research team.

Adam C Adler, MD

CONTACT

[email protected]

8328245800

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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