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| Name | Class |
|---|---|
| Baylor Scott and White Health | OTHER |
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To examine the difference in pain control in the pediatric general surgery population alternating acetaminophen and Ibuprofen q 3 hours vs giving them simultaneous combination therapy around the clock.
The purpose of the study is to compare the difference in pain control in the pediatric general surgery population of those who receive alternating acetaminophen and ibuprofen every 3 hours to those who receive acetaminophen and ibuprofen combined therapy around the clock. Additionally, to investigate the difference in parent adherence to pain treatment plans between the alternating group from the combined group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Group A will prescribe study participants in group 1 acetaminophen and ibuprofen alternating treatment every three hours. The dosage will be weight-based. |
|
| Group B | Active Comparator | Group B will be prescribed acetaminophen and ibuprofen combined treatment every 6 hours. The dosage will be weight-based. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | administered alternatively with other drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale. | Pain will be assessed using an age-appropriate pain rating scale. The FLACC is an interval scale quantifying pain behavior with scores ranging from 0 no pain behaviors to 10 most possible pain behaviors. The five categories of behaviors assessed with the FLAC include facial expressions, leg movement, activity, crying, and consolability. | 24, 48, and 72 hours after surgery |
| Pain Visual Analog Scale (VAS) | This tool portrays a 10cm ruler visual and the patient selects the marker indicating their pain intensity, 0 indicating no pain to 10 indicating the worst pain possible. | 24, 48, and 72 hours after surgery |
| Numeric Pain Rating Scale (NPRS) | The NPRS is scored on an 11-point scale where the higher the number indicating severe more the pain. | 24, 48, and 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Parent/ guardian adherence | Adherence will be assessed by asking the parent/guardian regarding their ability to follow pain regimen and the ease to follow the instructions. | 72 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
The study will take place at McLane Children's Hospital Temple Market. Patients who are pregnant.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White Health Temple Market | Temple | Texas | 76508 | United States |
Data-sharing considerations will be addressed upon receipt of a formal request. Upon receipt of a formal request, data sharing will proceed once a data-sharing agreement has been established. The rationale for the data sharing plan is that data obtained for the study is considered proprietary to BSWH.
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One group will be prescribed the acetaminophen and ibuprofen alternating every 3 hours. And the other group will be prescribed acetaminophen and ibuprofen combine treatment.
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| Ibuprofen |
| Drug |
administered alternatively with other drug |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 28, 2026 | Feb 13, 2026 | 2 |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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