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Phase 4 Completed N=110 Randomized Quadruple-blind Treatment

Prophylactic Pregabalin to Decrease Pain During Medical Abortion

Source: ClinicalTrials.gov NCT02782169 ↗
Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Maximum Pain Score Over Study Period — 5.0; 5.5 units on a scale — p=0.32
◆ Published Evidence
Established
24citations · ~3 / year
Prophylactic Pregabalin to Decrease Pain During Medication Abortion: A Randomized Controlled Trial.
Obstetrics and gynecology · 2018 · Likely link

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.

Linked Publications (2)

  • Prophylactic Pregabalin to Decrease Pain During Medication Abortion: A Randomized Controlled Trial.
    Obstetrics and gynecology · 2018 · 24 citations · Likely link
  • Pain management for medical abortion before 14 weeks' gestation.
    The Cochrane database of systematic reviews · 2022 · 18 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02782169) and the linked publication. 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. Informational only — not medical advice.

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