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| ID | Type | Description | Link |
|---|---|---|---|
| BPS-2023C1-32147 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute (PCORI) |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen/NSAID regimen | Other |
| |
| Acetaminophen/NSAID/Opioid regimen | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NSAID | Drug | Once randomized to this group the surgical team will elect to prescribe 1 of the following treatment options for post-discharge pain:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 14 days post-surgery, and 1 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 1 month after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Clark | Contact | 734-232-0324 | sarahmcl@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark Bicket, MD, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles (CHLA) | Recruiting | Los Angeles | California | 90027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42208996 | Derived | 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. |
| Label | URL |
|---|---|
| Project Summary on pcori.org | View source |
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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
Anticipated summer 2029 with no end date
Investigators can access the IPD and supporting information for analyses related to aims in the proposal. The proposed used of the data needs to be approved by a review committee and the sponsor. Proposals may be submitted up to 36 months after data availability, after which data will be available in a data warehouse but without investigator support.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D007052 | Ibuprofen |
| D000068579 | Celecoxib |
| D000701 | Analgesics, Opioid |
| D010098 | Oxycodone |
| D004091 | Hydromorphone |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
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Both study staff performing outcome assessment and data analysis will be masked to treatment assignment.
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Both study staff performing outcome assessment and data analysis will be masked to treatment assignment.
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| Opioid | Drug | 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:
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| Acetaminophen | Drug | 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) |
|
| Ibuprofen | Drug | 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) |
|
| 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). | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | Up to 12 months after surgery |
| Lucile Packard Children's Hospital Stanford | Recruiting | Palo Alto | California | 94304 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Nationwide Children's (NCH) | Recruiting | Columbus | Ohio | 43205 | United States |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D002491 | Central Nervous System Agents |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000814 | Aniline Compounds |
| D000588 | Amines |