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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Pain Outcomes Following Pediatric Adenotonsillectomy and the Impact on Non-Steroidal Anti-Inflammatory Drugs
- ClinicalTrials.gov ID
- NCT07672418
- Acronym / sponsor ID
- H59628
- Conditions
- Sleep, Pediatrics, Adenotonsillectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents undergoing outpatient adenotonsillectomy at Texas Children's Hospital Main Campus.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of severe postoperative pain
Time frame: Postoperative days 1, 3, 5, 7, 10
Pain score measured using the 0-10 Numeric Rating Scale after adenotonsillectomy.
1 secondary outcome
Incidence of severe postoperative pain
Time frame: Postoperative days 1, 3, 5, 7, 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidenitified data will be made available at study completion upon reasonable request and in accordance with institutional policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Pediatrics, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam C Adler, MD (8328245800, adam.adler@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe postoperative pain (time frame: Postoperative days 1, 3, 5, 7, 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.