Overnight Pain Treatment Investigating Opioids vs. Nonopioids

Abortion Second Trimester Clinical Trial

— OPTION  

Official title:

A Pilot Randomized Trial of Opioids Versus Nonopioids for Pain Control After Osmotic Dilator Placement for Abortion Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545893
• Other study ID #: 829723
• Status: Completed
• Phase: Phase 4
• Start date: June 19, 2018
• Est. completion date: February 7, 2019

Study information

• Verified date: March 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 7, 2019
• Est. primary completion date: February 7, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion Second Trimester

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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")	24 hours