Prophylactic Pregabalin to Decrease Pain During Medical Abortion

Acute Pain Clinical Trial

Official title:

Prophylactic Pregabalin to Decrease Pain During Medical Abortion: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782169
• Other study ID #: SFPRF15-12
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2015
• Last updated: April 17, 2018
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2018
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Medical abortion has been associated with significant pain. The objective of this trial is to determine whether one dose of pregabalin 300 mg, given during medical abortion in addition to the standard of care analgesics, will decrease experienced pain. Investigators will perform a randomized, double-blinded, placebo-controlled trial. Participant pain levels and side effects will be assessed at multiple time points, along with a measure of satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Requested and consented for pregnancy termination by medical abortion

• Willing and able to complete multiple electronic surveys

Exclusion Criteria:

• Previous participation in this trial

• Current use of pregabalin or gabapentin

• Contraindication to medical abortion with mifepristone and misoprostol

• Contraindication or allergy to ibuprofen, oxycodone, acetaminophen, or pregabalin

• Unable to understand and sign written informed consents in English

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Pregabalin
Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
• Placebo
Matching placebo capsule with excipient to match Pregabalin

Locations

Country	Name	City	State
United States	Women's Options Center	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
University of Hawaii	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Pain Score Over Study Period	reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain	Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
Secondary	Number of Ibuprofen 800mg Tablets Used	summed number of tablets used by each participant over the 72 hour study period	Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
Secondary	Number of Oxycodone/Acetominophen Tablets (5/325mg) Used	summed number of tablets used by each participant over the 72 hour study period	Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
Secondary	Number of Participants Ever Experiencing Different Symptoms During Abortion	A participant was included once if they ever reported a symptom during the 72 hour study period, not reflective of how long the symptom lasted. These were all commonly reported side effects during previous research on medication abortions and commonly reported side effects of pregabalin, so they were not included as adverse events.	Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
Secondary	Satisfaction With Analgesia	5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied)	Asked at time point of 24 hours