Prophylactic Pregabalin to Decrease Pain During Medical Abortion

University of Hawaii110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

110

Conditions

Acute Pain

Interventions

PregabalinDRUG

Pregabalin 300 mg capsule (over encapsulated to maintain blinding)

PlaceboDRUG

Matching placebo capsule with excipient to match Pregabalin

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Women's Options Center

Honolulu, Hawaii, United States

Outcomes

Primary Outcomes

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

Time frame: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)

Secondary Outcomes

Number of Ibuprofen 800mg Tablets Used

summed number of tablets used by each participant over the 72 hour study period

Time frame: 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

Time frame: 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.

Time frame: 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)

Time frame: Asked at time point of 24 hours

Data from ClinicalTrials.gov

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