Phase 4
N=70
Overnight Pain Treatment Investigating Opioids vs. Nonopioids
Abortion Second Trimester
Bottom Line
View on ClinicalTrials.gov: NCT03545893 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Maximum Pain Score — 4.66; 6.51 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ibuprofen 600 mg (Drug); OxyCODONE 5 Mg Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Pennsylvania
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Pain Score |
4.66; 6.51 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- English-speaking women
- 18 years or older
- Access to cell phone with text-messaging capability/data
- Receiving cervical preparation for induced abortion
- Able to complete baseline survey on smartphone/tablet at screening visit
Exclusion Criteria
- History of opioid or alcohol abuse
- Contraindications or allergy to ibuprofen
- Contraindications or allergy opioid medications
- Seeking uterine evacuation for premature preterm rupture of membranes or advanced - cervical dilation or intrauterine fetal demise
Data sourced from ClinicalTrials.gov (NCT03545893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.