Recruiting

Acetaminophen & Ibuprofen

Sponsor:

Baylor College of Medicine

Code:

NCT07672418

Conditions

Sleep

Pediatrics

Adenotonsillectomy

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Sleep

Pediatrics

Adenotonsillectomy

Study ID

NCT07672418

Start date

Jun 24, 2026

Status verified date

Sep, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Incidence of severe postoperative pain [ Time Frame: Postoperative days 1, 3, 5, 7, 10 ]

Central Contacts and Locations

Central contacts

Locations

Baylor College of Medicine/ Texas Childrens Hospital

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Baylor College of Medicine

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-09-08.