Baylor College of Medicine/ Texas Childrens Hospital
Houston, Texas, 77030, United States
NCT Number: NCT07672418
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.
Trial opening soon.
Get Notified13 year–18 year
All sexes
Observational
Houston, Texas, 77030, United States
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.
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
Time frame: Postoperative days 1-10
Pain score measured using the 0-10 Numeric Rating Scale after adenotonsillectomy.
Time frame: Postoperative days 1-10
Proportion of participants reporting severe pain, defined as Numeric Rating Scale score 7-10.
Time frame: Postoperative days 1-10
Participant-reported completion, missed doses, or non-use of prescribed postoperative analgesics.
Time frame: Postoperative days 1-10
Proportion of participants presenting to the emergency department or urgent care for pain related to adenotonsillectomy.
Contact information is provided by the study sponsor or research team.
Baylor College of Medicine
Other
Assessment of Postoperative Pain Outcomes Following Pediatric Adenotonsillectomy and the Impact on Non-Steroidal Anti-Inflammatory Drugs
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