Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 13 Years and 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Cohort 1: Acetaminophen + Ibuprofen Participants prescribed acetaminophen and ibuprofen after discharge according to routine clinical practice.
Cohort 2: Acetaminophen + Oral Ketorolac Participants prescribed acetaminophen and low-dose oral ketorolac after discharge according to routine clinical practice.

Recruiting Locations

Baylor College of Medicine/ Texas Childrens Hospital
Houston, Texas 77030

More Details

Status
Recruiting
Sponsor
Baylor College of Medicine

Study Contact

Adam C Adler, MD
8328245800
adam.adler@bcm.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.