Prophylactic Pregabalin to Decrease Pain During Medical Abortion

University of Hawaii

Status and phase: Completed; Phase 4

Conditions: Acute Pain

Treatments: Drug: Pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02782169

SFPRF15-12

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

Pregabalin

Active Comparator group

Treatment:

Drug: Pregabalin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo