Overnight Pain Treatment Investigating Opioids vs. Nonopioids

Phase 4

Completed

• Conditions: Abortion Second Trimester
• Interventions: Drug: Ibuprofen 600 mg; Drug: OxyCODONE 5 Mg Oral Tablet

• Registration Number: NCT03545893
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-04
• Study Start: 2018-06-19
• Primary Completion: 2019-02-07
• Study Completion: 2019-02-07
• Status Verified: 2020-03
• Results First Submitted: 2020-03-05
• Results First Submitted QC: 2020-03-24
• Last Update Submitted: 2020-03-24
• Results First Posted: 2020-03-25
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen	Ibuprofen 600 mg	-
Ibuprofen + Oxycodone	Ibuprofen 600 mg	-
Ibuprofen + Oxycodone	OxyCODONE 5 Mg Oral Tablet	-

Primary Outcome Measures

Name	Time	Method
Maximum Pain Score	24 hours	Numerical Rating Scale (NRS) pain score (scale range 0-10, with a 0 meaning "no pain" and 10 meaning the "worst possible pain")

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States