CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
Ibuprofen 600 mg +1 moredrug
Likely dose
Ibuprofen 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03545893
NCT03545893Phase 4Completed
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A Pilot Randomized Trial of Opioids Versus Nonopioids for Pain Control After Osmotic Dilator Placement for Abortion Care

University of Pennsylvania·interventional·Posted Jun 4, 2018·Updated Mar 25, 2020

In Brief

A Phase 4 clinical trial evaluating Ibuprofen 600 mg and OxyCODONE 5 Mg Oral Tablet for Abortion Second Trimester. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbortion Second Trimester
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJun 4, 2018
Enrollment StartJun 19, 2018
Primary CompletionFeb 7, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.1 years ago

Interventions

Ibuprofen 600 mgdrug

Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.

OxyCODONE 5 Mg Oral Tabletdrug

Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain.