Overnight Pain Treatment Investigating Opioids vs. Nonopioids

NCT ID: NCT03545893

Last Updated: 2020-03-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-19

Study Completion Date

2019-02-07

Brief Summary

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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.

Detailed Description

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Conditions

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Abortion Second Trimester

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ibuprofen

Group Type ACTIVE_COMPARATOR

Ibuprofen 600 mg

Intervention Type DRUG

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

Ibuprofen + Oxycodone

Group Type ACTIVE_COMPARATOR

Ibuprofen 600 mg

Intervention Type DRUG

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

OxyCODONE 5 Mg Oral Tablet

Intervention Type DRUG

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

Interventions

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Ibuprofen 600 mg

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

Intervention Type DRUG

OxyCODONE 5 Mg Oral Tablet

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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829723

Identifier Type: -

Identifier Source: org_study_id

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