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After reviewing our enrollment numbers and feasibility, we have decided to close the study due to low enrollment.
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There are two common and concurrently used strategies for pain management following surgical treatment of supracondylar humerus (elbow) fractures in children: opioids vs over the counter pain medications. The purpose of this study is to determine if ibuprofen and acetaminophen can provide similar or better pain relief compared to ibuprofen and hydrocodone/acetaminophen (also known as Hycet) for this population of children after they have been discharged. If over the counter medications can provide adequate pain relief, then fewer opioid prescriptions would be necessary. This reduces early opioid exposure and decreases unnecessary opioids in circulation.
Prior to surgery, participants will be randomly assigned to a group that will determine whether they are prescribed an opioid vs non-opioid pain management plan at discharge. Each participants' parent or guardian will be given a journal to keep track of their child's pain severity and the pain medications taken. The journal will updated daily until participants no longer require pain medication. Participants will follow up with their surgeon per usual at their post-operative visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid Pain Management | Active Comparator | Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain. |
|
| Non-Opioid Pain Management | Experimental | Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | Non-opioid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily Pain Scores on the FACES Scale | A parent/guardian will ask participants to rate their pain severity using the Wong-Baker FACES scale, which ranges from 0 (no pain) to 10 (worst pain). | from discharge until pain medication is no longer required (assessed up to 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Pain Medication Required | A parent/guardian will record the doses of pain medications given to the participant each day. | from discharge until pain medication is no longer required (assessed up to 3 weeks) |
| Number of Pain Medication Doses Required Per Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Rosenfeld, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital - Main Campus | Houston | Texas | 77030 | United States | ||
| Texas Children's Hospital - West Campus |
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| ID | Title | Description |
|---|---|---|
| FG000 | Opioid Pain Management | Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain. |
| FG001 | Non-Opioid Pain Management | Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Opioid Pain Management | Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain. |
| BG001 | Non-Opioid Pain Management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Daily Pain Scores on the FACES Scale | A parent/guardian will ask participants to rate their pain severity using the Wong-Baker FACES scale, which ranges from 0 (no pain) to 10 (worst pain). | Only 8 opioid and 5 non-opioid patients completed the pain journal, so they are the only patients who could be analyzed. | Posted | Mean | Standard Deviation | scores on a scale/day | from discharge until pain medication is no longer required (assessed up to 3 weeks) |
|
From enrollment until end of follow-up, up to 4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Opioid Pain Management | Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain. |
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The study was terminated early due to insufficient enrollment, resulting in inadequate data to meaningfully assess the primary outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SCOTT ROSENFELD, MD | Baylor College of Medicine/ Texas Children's Hospital | 832-824-1000 | sbrosenf@texaschildrenshospital.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2026 | Jan 17, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| C514822 | oxycodone-acetaminophen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Hydrocodone/acetaminophen | Drug | Opioid |
|
|
| Acetaminophen | Drug | Non-opioid |
|
|
A parent/guardian will record the doses of pain medications given to the participant each day. |
| from discharge until pain medication is no longer required (assessed up to 3 weeks) |
| Houston |
| Texas |
| 77094 |
| United States |
| Texas Children's Hospital - Woodlands Campus | Houston | Texas | 77384 | United States |
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain. |
|
|
| Secondary | Number of Days Pain Medication Required | A parent/guardian will record the doses of pain medications given to the participant each day. | Only 8 opioid and 5 non-opioid patients completed the pain journal, so they are the only patients who could be analyzed. | Posted | Mean | Standard Deviation | days | from discharge until pain medication is no longer required (assessed up to 3 weeks) |
|
|
|
| Secondary | Number of Pain Medication Doses Required Per Day | A parent/guardian will record the doses of pain medications given to the participant each day. | Only 8 opioid and 5 non-opioid patients completed the pain journal, so they are the only patients who could be analyzed. | Posted | Mean | Standard Deviation | doses of medication/day | from discharge until pain medication is no longer required (assessed up to 3 weeks) |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Non-Opioid Pain Management | Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |