SurgeryPhase 4CARES for KidsNCT06671002
Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial
A Phase 4 study testing NSAID, Opioid and Acetaminophen in people with Surgery and Pain, Post Operative, run by University of Michigan at 9 sites in United States.
Trial summary
This trial is being completed to compare two commonly used options to treat pain after discharge from surgery. Participants that undergo tonsil removal, gallbladder removal, and knee scope will be eligible to enroll. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Surgery, Pain, Post Operative
- What is being tested?
- NSAID, Opioid and Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 9 sitesUnited States
- Study dates
- 10 Jan 2025to 31 Oct 2027
- Phase
- Phase 4
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 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- No significant analgesic medication use before surgery as defined in the protocol. For this study, we define significant analgesic medication use before surgery as prescriptions reported by the child or caregiver for 6 days or more of opioid medications in the past 90 days (aligning with American Pediatric Guidelines that were published in September 2024 after the project was funded), excepting surgical team prescriptions within the week of surgery.
- Undergo one the following: tonsil removal (with or without adenoid removal), gallbladder removal (laparoscopic), and knee scope (arthroscopy).
Who cannot join
- Anticipated other surgery within 12 months
- Anticipated life expectancy of <12 months
- Those that have legal guardians (due to special permission to enroll in trials)
- Participants with complex chronic conditions per the Pediatric Medical Complexity Algorithm (e.g., trisomy 21)
- Patients with contraindications to non-steroidal anti-inflammatory drug (NSAID) drugs in the NSAID arm, opioid drugs in the opioid arm, or acetaminophen will be excluded.
- Liver disease
- Acute psychiatric instability (defined as current uncontrolled severe depression, severe post-traumatic stress disorder (PTSD), or suicidal ideation), substance use disorder not in remission or treatment, and history of diversion of controlled substances (opioids)
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 5 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Sarah Clark, 734-232-0324, sarahmcl@umich.edu
Mark Bicket, MD, PhD
- Active, not recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
- Not yet recruiting
Cincinnati Children's
Cincinnati, Ohio, 45229
Erin Waters, 513-803-7024, Erin.Watters@cchmc.org
Justin Lee, MD
- Recruiting
Nationwide Children's (NCH)
Columbus, Ohio, 43205
Taha Akbar, BS, 614-355-4526, taha.akbar@nationwidechildrens.org
Sara Mansfield, MD
- Active, not recruiting
Kapi'olani Medical Center for Women & Children
Honolulu, Hawaii, 96826
- Recruiting
Children's Hospital Los Angeles (CHLA)
Los Angeles, California, 90027
Nikhita Datar, MS, 323-361-7218, ndatar@chla.usc.edu
Lorraine Kelley-Quon, MD
- Active, not recruiting
Children's Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
Ryan Ma, BA, 650-665-9074, ryanma@stanford.edu
Jennifer Rabbitts, MD
- Active, not recruiting
Phoenix Children's
Phoenix, Arizona, 85016
About this study
Official title: Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids (CARES for Kids) Trial
This trial is being completed to compare two commonly used options to treat pain after discharge from surgery. Participants that undergo tonsil removal, gallbladder removal, and knee scope will be eligible to enroll. Eligible participants will be randomized to prescription of 1 of 2 groups of medications (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) plus acetaminophen or low dose opioids with the NSAIDs plus acetaminophen. The key question the study seeks to answer is which option will have the best outcomes and with the fewest side effects?
- Conditions
- Surgery, Pain, Post Operative
- Being tested
- NSAID, Opioid, Acetaminophen, Ibuprofen
- Keywords
- Medications after surgery, NSAIDS, Acetaminophen, Opioids, Analgesics, non-narcotic, Tonsil removal, Gallbladder removal, Knee scope, Analgesics, opioid
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAIDDrug
Also called Ibuprofen, Celecoxib
Once randomized to this group the surgical team will elect to prescribe 1 of the following treatment options for post-discharge pain:
- Ibuprofen 10 milligrams(mg)/kilogram (kg) (maximum 600mg) by mouth every 6 hours around the clock for 2 days, then as needed for pain thereafter (40 doses)
- Celecoxib 6mg/kg (maximum 400mg) by mouth once then 3 mg/kg (maximum 200mg) every 12 hours around the clock for 2 days, then as needed for pain thereafter (40 doses)
OpioidDrug
Also called Oxycodone, Hydromorphone
Once randomized to this group the surgical team will elect to prescribe for 1 of the following treatment options to be given post procedure for post-discharge pain:
- Oxycodone 0.1 mg/kg (maximum 5 mg) by mouth every 4 to 6 hours as needed for pain, number 10 doses.
- Hydromorphone 0.04 mg/kg (maximum mg) by mouth 4 to 6 hours as needed, number 10 doses
AcetaminophenDrug
Participants will receive 15mg/kg up to 1000mg by mouth every 6 hours around the clock for the first 2 days after discharge from surgery then as needed thereafter (40 doses)
IbuprofenDrug
Ibuprofen 10mg/kg (maximum 600 mg) by mouth every 6 hours around the clock for 2 days after discharge from surgery then as needed thereafter (40 doses)
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen/NSAID regimen | Other | Not described Receives: Drug: NSAID; Drug: Acetaminophen |
| Acetaminophen/NSAID/Opioid regimen | Other | Not described Receives: Drug: Opioid; Drug: Acetaminophen; Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness outcome - Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 14 days post-surgery
This is a one question survey in which the worst pain intensity recorded (0-10 being the worst) will be used.
Measured: 14 days post-surgery, and up to 12 months after surgery
Safety outcome - number and severity of any adverse medication-related symptoms over 14 days post-surgery
Symptom Checklist will proactively screen patients for reports of adverse events from analgesic medications over the first 14 days post-surgery.
Measured: 14 days post-surgery, and 1 month after surgery
Secondary outcomes (16)
Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance v1.0 short form 4a
This is a 4-question survey in which participants will rate statements pertaining to quality of sleep. Participants will also rate sleep quality as very poor (5), poor (4), fair (3), good (2), or very good (1).
Measured: Baseline and 1 month after surgery
Patient Global Impression of Change (PGIC)
The perception of improvement or worsening after treatment will be assessed by the patient global impression of change PGIC (range 0-7).
Measured: Day 7 up to 12 months after surgery
PROMIS Pediatric Pain Interference scale (Short form-8a)
This is an 8-question survey in which participants will rate statements pertaining to how pain interferes with activities and function.
Measured: Baseline up to 12 months after surgery
Pain Catastrophizing Scale (PCS)
This is a 6-question survey in which participants will rate statements pertaining to their experience of pain.
Measured: Baseline up to 12 months after surgery
Pediatric Quality of Life Inventory Short Form 15
There are 15 questions with four scales for function related to physical, emotional, social, and school dimensions for adolescents. Participants answer questions from never (0) to almost always (4).
Measured: Baseline up to 12 months after surgery
Quality of Recovery (QoR) 15
There are 15 questions assessed on a scale of 1-10, with 0 being none of the time and 10 being all of the time, 10 being the better outcome.
Measured: Day 3, 1 week, and 2 weeks after surgery
Patient Health Questionnaire (PHQ-2)
There are 2 questions that are completed to screen for depression. Participants answer from not at all (0) to Nearly every day (3). The scores range from 0-6 with a higher score indicating higher levels of depression.
Measured: Baseline up to 12 months after surgery
Generalized Anxiety Disorder (GAD-2)
There are 2 questions that are completed to screen for anxiety. Participants answer from not at all (0) to Nearly every day (3). The scores range from 0-6 with a higher score indicating higher levels of anxiety.
Measured: Baseline up to 12 months after surgery
Brief Screening Instrument for Adolescent Tobacco, Alcohol, and Drug Use
This is a 6-question survey about the participants' use of tobacco, alcohol and drugs.
Measured: Baseline up to 12 months after surgery
National Survey on Drug Use and Health Questions on Opioid Misuse
This is a one question survey that assesses opioid misuse defined as use that is more than prescribed, for non pain-related reasons, or in a way not prescribed by a doctor.
Measured: Baseline up to 12 months after surgery
New prolonged opioid use
One question that will assess opioid prescription fills to identify new prolonged opioid use after surgery
Measured: Up to 12 months after surgery
Acute pain based on The Michigan Body Map
Participants will document/mark on this image map to identify areas in which acute pain was felt.
Measured: Up to 12 months after surgery
Chronic pain based on Body Map
Participants will document/mark on this image map to identify areas in which persistent or recurrent pain was felt.
Measured: Up to 12 months after surgery
Chronic pain based on Brief Pain Inventory (BPI) pain intensity score up to 12 months after surgery
One question survey in which the participants rate pain intensity recorded (0-10), ten being the worst.
Measured: to 12 months after surgery
Healthcare Utilization related to pain
Participants will answer questions about their healthcare utilization related to pain for the following three events: (1) postoperative clinical interactions related to pain in the form of patient messages, phone calls, and non-routine clinic visits related to pain, (2) emergency room visits, and (3) hospitalizations. The study team will also review health record for the same events.
Measured: Up to 12 months after surgery
Analgesic medication use
Participants will answer questions about their analgesic medication use for acetaminophen, NSAIDs, opioids, and other medications, including prescription fills, over-the-counter use, and consumption. The study team will also review health record for prescription fills.
Measured: Up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start10 Jan 2025
- Primary completion16 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both study staff performing outcome assessment and data analysis will be masked to treatment assignment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Mark Bicket, MD, PhD, University of Michigan
- Investigators
- Mark Bicket, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671002
- Sponsor's protocol ID
- HUM00252793
- Other IDs
- BPS-2023C1-32147
- Acronym
- CARES for Kids
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results of the trial that is not subject to restrictions based on data sharing agreements (e.g., prescription drug monitoring program data), after deidentification
Publications
Lee JS, Bicket MC, Mansfield SA, Rabbitts JA, Van Horn A, Perrone EE, Chua KP, Voepel-Lewis T, Waljee J, Brummett C, Hutmacher C, Li Y, Kelley-Quon LI; CARES for Kids Investigators. US multicentre randomised controlled trial protocol: Comparing Analgesic Regimen Effectiveness and Safety after surgery trial for Kids (CARES for Kids). BMJ Open. 2026 May 28;16(5):e118728. doi: 10.1136/bmjopen-2026-118728.
PubMed 42208996