Postoperative Pain After Pediatric Adenotonsillectomy With Ketorolac or Ibuprofen

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep; Adenotonsillectomy; Pediatrics

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Adam C Adler, MD; Phone Number: 8328245800; Email: adam.adler@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine/ Texas Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of severe postoperative pain	Pain score measured using the 0-10 Numeric Rating Scale after adenotonsillectomy.	Postoperative days 1-10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of severe postoperative pain	Proportion of participants reporting severe pain, defined as Numeric Rating Scale score 7-10.	Postoperative days 1-10

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication administration after discharge	Participant-reported completion, missed doses, or non-use of prescribed postoperative analgesics.	Postoperative days 1-10
Emergency department or urgent care visit for pain	Proportion of participants presenting to the emergency department or urgent care for pain related to adenotonsillectomy.	Postoperative days 1-10

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 24, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: H59628

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidenitified data will be made available at study completion upon reasonable request and in accordance with institutional policy.
• IPD Sharing Time Frame: Following Study completion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No