Overnight Pain Treatment Investigating Opioids vs. Nonopioids (OPTION)

University of Pennsylvania

Status and phase: Completed; Phase 4

Conditions: Abortion Second Trimester

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03545893

829723

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Ibuprofen

Active Comparator group

Treatment:

Drug: Ibuprofen 600 mg

Ibuprofen + Oxycodone

Active Comparator group

Treatment:

Drug: OxyCODONE 5 Mg Oral Tablet

Drug: Ibuprofen 600 mg