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OpenTrials
Completed

NCT Number: NCT02782169

Prophylactic Pregabalin to Decrease Pain During Medical Abortion

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Women's Options Center

Honolulu, Hawaii, 96826, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

Pregabalin 300 mg capsule (over encapsulated to maintain blinding)

Placebo

Drug

Matching placebo capsule with excipient to match Pregabalin

Primary outcomes

  1. Maximum Pain Score Over Study Period

    Time frame: 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 outcomes

  1. Number of Ibuprofen 800mg Tablets Used

    Time frame: 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

  2. Number of Oxycodone/Acetominophen Tablets (5/325mg) Used

    Time frame: 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

  3. Number of Participants Ever Experiencing Different Symptoms During Abortion

    Time frame: 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.

  4. Satisfaction With Analgesia

    Time frame: Asked at time point of 24 hours

    5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied)

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 25, 2016
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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