A Phase 4 interventional study of Ibuprofen 600 mg and OxyCODONE 5 Mg Oral Tablet in Abortion Second Trimester, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-25.
Sponsored by University of Pennsylvania · Phase 4, Interventional, and Treatment
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.
University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Ibuprofen 600 mg
Drug: Ibuprofen 600 mg · Drug: OxyCODONE 5 Mg Oral Tablet
Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain.
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")
Time frame: 24 hours
| Milestone | Ibuprofen | Ibuprofen + Oxycodone |
|---|---|---|
| Started | 35 | 35 |
| Completed | 35 | 35 |
| Not completed | 0 | 0 |
Numerical Rating Scale (NRS) pain score (scale range 0-10, with a 0 meaning "no pain" and 10 meaning the "worst possible pain")
| score on a scale | Ibuprofen | Ibuprofen + Oxycodone |
|---|---|---|
| Maximum Pain Score | 4.66 ± 2.86 | 6.51 ± 2.50 |
Collected over 2 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ibuprofen | 0/35 (0%) | 0/35 (0%) | 35/35 (100%) |
| Ibuprofen + Oxycodone | 0/35 (0%) | 0/35 (0%) | 35/35 (100%) |
| Event | Ibuprofen | Ibuprofen + Oxycodone |
|---|---|---|
| Uterine CrampingReproductive system and breast disorders | 29/35 | 29/35 |
| Vaginal spottingReproductive system and breast disorders | 18/35 | 22/35 |
| NauseaGastrointestinal disorders | 11/35 | 18/35 |
| Vaginal bleedingReproductive system and breast disorders | 6/35 | 12/35 |
| DrowsinessNervous system disorders | 2/35 | 7/35 |
| Uterine painReproductive system and breast disorders | 4/35 | 6/35 |
| DizzinessNervous system disorders | 2/35 | 6/35 |
| ItchingSkin and subcutaneous tissue disorders | 3/35 | 2/35 |
| Age, Continuous(years) | Ibuprofen | Ibuprofen + Oxycodone | Total |
|---|---|---|---|
| Mean | 30.2 ± 7.7 | 30.9 ± 8.6 | 30.6 ± 8.1 |
| Sex: Female, Male(Participants) | Ibuprofen | Ibuprofen + Oxycodone | Total |
|---|---|---|---|
| Female | 35 | 35 | 70 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Ibuprofen | Ibuprofen + Oxycodone | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 3 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 19 | 18 | 37 |
| White | 11 | 10 | 21 |
| More than one race | 3 | 4 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Ibuprofen | Ibuprofen + Oxycodone | Total |
|---|---|---|---|
| United States | 35 | 35 | 70 |
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University of Pennsylvania