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Overnight Pain Treatment Investigating Opioids vs. Nonopioids (OPTION)

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ClinicalTrials.gov Identifier: NCT03545893
Recruitment Status : Completed
First Posted : June 4, 2018
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Abortion Second Trimester Drug: Ibuprofen 600 mg Drug: OxyCODONE 5 Mg Oral Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Randomized Trial of Opioids Versus Nonopioids for Pain Control After Osmotic Dilator Placement for Abortion Care
Actual Study Start Date : June 19, 2018
Actual Primary Completion Date : February 7, 2019
Actual Study Completion Date : February 7, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ibuprofen Drug: Ibuprofen 600 mg
Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.

Active Comparator: Ibuprofen + Oxycodone Drug: Ibuprofen 600 mg
Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.

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




Primary Outcome Measures :
  1. Maximum pain score [ Time Frame: 24 hours ]
    Numerical Rating Scale (NRS) pain score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545893


Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19143
Sponsors and Collaborators
University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03545893     History of Changes
Other Study ID Numbers: 829723
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Oxycodone
Ibuprofen
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants