Postoperative Pain After Pediatric Adenotonsillectomy With Ketorolac or Ibuprofen

NCT07672418 | Not Yet Recruiting

• 1 other identifier: H59628
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of severe postoperative pain

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

  Postoperative days 1-10

Secondary Outcomes (1)

• Incidence of severe postoperative pain

  Postoperative days 1-10

Other Outcomes (2)

• Medication administration after discharge

  Postoperative days 1-10

• Emergency department or urgent care visit for pain

  Postoperative days 1-10

Study Arms (2)

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.

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents undergoing outpatient adenotonsillectomy at Texas Children's Hospital Main Campus.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine/ Texas Childrens Hospital

Houston, Texas, 77030, United States

Location

Central Study Contacts

Adam C Adler, MD

CONTACT

8328245800; adam.adler@bcm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology and Surgery

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: June 24, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Following Study completion

Locations

US (1)