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The purpose of this study is to compare maximum pain scores between patients seeking induced abortion and requiring cervical preparation with osmotic dilators. Patients will be randomized to receive prescription for ibuprofen alone or to receive prescription for ibuprofen + oxycodone for overnight pain management after cervical preparation with osmotic dilators. Data collected in-person and through a text-messaging platform.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Active Comparator |
| |
| Ibuprofen + Oxycodone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 600 mg | Drug | Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Pain Score | Numerical Rating Scale (NRS) pain score (scale range 0-10, with a 0 meaning "no pain" and 10 meaning the "worst possible pain") | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen | Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain. |
| FG001 | Ibuprofen + Oxycodone | Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain. OxyCODONE 5 Mg Oral Tablet: Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen | Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain. |
| BG001 | Ibuprofen + Oxycodone | Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain. OxyCODONE 5 Mg Oral Tablet: Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain. |
| 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 | Maximum Pain Score | Numerical Rating Scale (NRS) pain score (scale range 0-10, with a 0 meaning "no pain" and 10 meaning the "worst possible pain") | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
|
2 days
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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 | Ibuprofen | Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arden McAllister, Research Program Manager | University of Pennsylvania | 215-662-3532 | arden.mcallister@pennmedicine.upenn.edu |
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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 | May 9, 2018 | Mar 4, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D010098 | Oxycodone |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| OxyCODONE 5 Mg Oral Tablet | Drug | Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 35 |
| 35 |
| EG001 | Ibuprofen + Oxycodone | Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain. OxyCODONE 5 Mg Oral Tablet: Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain. | 0 | 35 | 0 | 35 | 35 | 35 |
| Uterine Cramping | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Vaginal spotting | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Vaginal bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Uterine pain | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Drowsiness | Nervous system disorders | Non-systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D003061 |
| Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| 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 |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |