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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03545893
Other study ID # 829723
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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