Overnight Pain Treatment Investigating Opioids vs. Nonopioids

NCT03545893 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 829723
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abortion Second Trimester

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ibuprofen

ACTIVE COMPARATOR

Drug: Ibuprofen 600 mg

Ibuprofen + Oxycodone

ACTIVE COMPARATOR

Drug: Ibuprofen 600 mg; Drug: OxyCODONE 5 Mg Oral Tablet

Interventions

Ibuprofen 600 mg DRUG

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

Ibuprofen; Ibuprofen + Oxycodone

OxyCODONE 5 Mg Oral Tablet DRUG

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

Ibuprofen + Oxycodone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking women
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19143, United States

Location

MeSH Terms

Interventions

Ibuprofen; Oxycodone; Tablets

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Arden McAllister, Research Program Manager
• Organization: University of Pennsylvania

arden.mcallister@pennmedicine.upenn.edu

215-662-3532

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 4, 2018
• Study Start: June 19, 2018
• Primary Completion: February 7, 2019
• Study Completion: February 7, 2019
• Last Updated: March 25, 2020
• Results First Posted: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)