Opioid Analgesia for MAB

Pain Clinical Trial

Official title:

Opioid Analgesia for MAB: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139240
• Other study ID #: 16845
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: August 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our primary objective will be to determine if a strong opioid, oxycodone, given at a dose recommended for severe pain in addition to ibuprofen decreases maximum pain scores compared to ibuprofen and placebo in women undergoing medical abortion (MAB). Results of this study will help future providers understand whether prescribing opioids are an important adjunct for pain control in women undergoing MAB.

Description:

This study will include 152 women undergoing MAB. Women will be randomized to oxycodone 10mg oral versus placebo and stratified by gestational age (<7wks, 7-10wks). The primary outcome will be maximum reported pain score measured at 6-8 hours and 24 hours after misoprostol administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Aged 18 years or older

• Seeking elective medical abortion

• In good health

• Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound

• Able and willing to receive text messages via phone

• Literate in English

• Able and willing to give informed consent and agree to the study terms

• Have assistance at home; no motor vehicle use while taking study medications

Exclusion Criteria:

• Lack of access to cell phone and texting capabilities

• Early pregnancy failure

• Contraindications to the study medications: Oxycodone, Ibuprofen

• Contraindications to medical abortion with Mifepristone or Misoprostol

• History of methadone or heroin use

• Used alcohol in the past 24 hours

• Used marijuana >4 times per week

• Any opioid in the past 30 days

• Using additional pain medications

Related Conditions & MeSH terms

• MAB
• Pain

Intervention

Drug:
• Oxycodone 10mg oral
Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion

Other:
• Placebo
Placebo given in addition to standard of care medications in women undergoing medical abortion

Locations

Country	Name	City	State
United States	Site 1	Beaverton	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Maximum Self-reported Pain Score	Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).	24 hours after misoprostol administration
Primary	<7 Weeks of Gestation - Maximum Self-reported Pain Score	Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).	24 hours after misoprostol administration
Primary	7-10 Weeks Gestation - Maximum Self-reported Pain Score	Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).	24 hours after misoprostol administration