Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prophylactic Pregabalin to Decrease Pain During Medical Abortion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02782169
Recruitment Status : Completed
First Posted : May 25, 2016
Results First Posted : April 19, 2018
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Pregabalin Drug: Placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prophylactic Pregabalin to Decrease Pain During Medical Abortion: a Randomized Controlled Trial
Actual Study Start Date : June 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Active Comparator: Pregabalin Drug: Pregabalin
Pregabalin 300 mg capsule (over encapsulated to maintain blinding)

Placebo Comparator: Placebo Drug: Placebo
Matching placebo capsule with excipient to match Pregabalin




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782169


Locations
Layout table for location information
United States, Hawaii
Women's Options Center
Honolulu, Hawaii, United States, 96826
Sponsors and Collaborators
University of Hawaii
Society of Family Planning
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT02782169    
Other Study ID Numbers: SFPRF15-12
First Posted: May 25, 2016    Key Record Dates
Results First Posted: April 19, 2018
Last Update Posted: April 19, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Pain
Pain
Neurologic Manifestations
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs