Phase 4
N=110
Prophylactic Pregabalin to Decrease Pain During Medical Abortion
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT02782169 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Maximum Pain Score Over Study Period — 5.0; 5.5 units on a scale — p=0.32
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pregabalin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Hawaii
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Pain Score Over Study Period |
5.0; 5.5 | 0.32 |
| SECONDARY Number of Ibuprofen 800mg Tablets Used |
1; 2 | — |
| SECONDARY Number of Oxycodone/Acetominophen Tablets (5/325mg) Used |
0; 0.5 | — |
| SECONDARY Number of Participants Ever Experiencing Different Symptoms During Abortion |
43; 42; 28; 30; 47; 39 | — |
| SECONDARY Satisfaction With Analgesia |
2; 3; 3; 0; 12; 13 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02782169). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.