Prophylactic Pregabalin to Decrease Pain During Medical Abortion
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility 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
Sites / Locations
- Women's Options Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Pregabalin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of Ibuprofen 800mg Tablets Used
summed number of tablets used by each participant over the 72 hour study period
Number of Oxycodone/Acetominophen Tablets (5/325mg) Used
summed number of tablets used by each participant over the 72 hour study period
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.
Satisfaction With Analgesia
5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied)
Full Information
NCT ID
NCT02782169
First Posted
November 30, 2015
Last Updated
April 17, 2018
Sponsor
University of Hawaii
Collaborators
Society of Family Planning
1. Study Identification
Unique Protocol Identification Number
NCT02782169
Brief Title
Prophylactic Pregabalin to Decrease Pain During Medical Abortion
Official Title
Prophylactic Pregabalin to Decrease Pain During Medical Abortion: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hawaii
Collaborators
Society of Family Planning
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregabalin
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsule with excipient to match Pregabalin
Primary Outcome Measure Information:
Title
Maximum Pain Score Over Study Period
Description
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 Outcome Measure Information:
Title
Number of Ibuprofen 800mg Tablets Used
Description
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)
Title
Number of Oxycodone/Acetominophen Tablets (5/325mg) Used
Description
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)
Title
Number of Participants Ever Experiencing Different Symptoms During Abortion
Description
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)
Title
Satisfaction With Analgesia
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Women's Options Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35553047
Citation
Reynolds-Wright JJ, Woldetsadik MA, Morroni C, Cameron S. Pain management for medical abortion before 14 weeks' gestation. Cochrane Database Syst Rev. 2022 May 13;5(5):CD013525. doi: 10.1002/14651858.CD013525.pub2.
Results Reference
derived
PubMed Identifier
30095762
Citation
Friedlander EB, Soon R, Salcedo J, Davis J, Tschann M, Kaneshiro B. Prophylactic Pregabalin to Decrease Pain During Medication Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):612-618. doi: 10.1097/AOG.0000000000002787.
Results Reference
derived
Learn more about this trial
Prophylactic Pregabalin to Decrease Pain During Medical Abortion
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