Prophylactic Pregabalin to Decrease Pain During Medical Abortion

Phase 4

Completed

• Conditions: Acute Pain
• Interventions: Drug: Placebo; Drug: Pregabalin

• Registration Number: NCT02782169
• Lead Sponsor: University of Hawaii

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-25
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Results First Submitted: 2018-01-24
• Status Verified: 2018-04
• Results First Submitted QC: 2018-04-17
• Last Update Submitted: 2018-04-17
• Results First Posted: 2018-04-19
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• Requested and consented for pregnancy termination by medical abortion
• Willing and able to complete multiple electronic surveys

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Pregabalin	Pregabalin	-

Primary Outcome Measures

Name	Time	Method
Maximum Pain Score Over Study Period	Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)	reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain

Secondary Outcome Measures

Name	Time	Method
Number of Ibuprofen 800mg Tablets Used	Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)	summed number of tablets used by each participant over the 72 hour study period
Number of Oxycodone/Acetominophen Tablets (5/325mg) Used	Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)	summed number of tablets used by each participant over the 72 hour study period
Number of Participants Ever Experiencing Different Symptoms During Abortion	Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)	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.
Satisfaction With Analgesia	Asked at time point of 24 hours	5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied)

Trial Locations

Locations (1)

Women's Options Center; 🇺🇸 Honolulu, Hawaii, United States