SleepNCT07672418
Postoperative Pain After Pediatric Adenotonsillectomy With Ketorolac or Ibuprofen
An observational study of Sleep and Pediatrics, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Sleep, Pediatrics, Adenotonsillectomy
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2026to 30 Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents undergoing outpatient adenotonsillectomy at Texas Children's Hospital Main Campus.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor College of Medicine/ Texas Childrens Hospital
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep, Pediatrics, Adenotonsillectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe postoperative pain
Pain score measured using the 0-10 Numeric Rating Scale after adenotonsillectomy.
Measured: Postoperative days 1, 3, 5, 7, 10
Secondary outcomes (1)
Incidence of severe postoperative pain
Proportion of participants reporting severe pain, defined as Numeric Rating Scale score 7-10.
Measured: Postoperative days 1, 3, 5, 7, 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start24 Jun 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Adler MD, MS, FAAP, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672418
- Sponsor's protocol ID
- H59628
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidenitified data will be made available at study completion upon reasonable request and in accordance with institutional policy.