Prophylactic Pregabalin to Decrease Pain During Medical Abortion

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pregabalin<br> | Drug: Pregabalin<br>* Pregabalin 300 mg capsule (over encapsulated to maintain blinding)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching placebo capsule with excipient to match Pregabalin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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 |