Gabapentin for Pain Management During Dilation and Evacuation

• Status: Completed
• Trial end date: 2020-05-20
• Target enrollment: 0
• Participant gender: Female

Summary

Justification. Pain control is still an issue for women undergoing second trimester abortion procedures. The investigators propose a randomized controlled double-blinded trial evaluating the use of adjunct gabapentin versus placebo in addition to moderate sedation during D&E. The investigators hypothesize that 600 mg oral gabapentin administered pre-operatively at the time of cervical preparation initiation will improve intra-operative pain control. The investigators also hypothesize that it will improve pre- and post-operative pain, anxiety, nausea, vomiting, and overall satisfaction with pain management during D&E.

To test the hypotheses the investigators plan to enroll 130 participants who will be randomized 1 to 1 to receive either 600 mg gabapentin or placebo at the initiation of cervical preparation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medstar Health Research Institute
• Collaborator: Society of Family Planning Research Fund
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

Inclusion Criteria:

• English proficiency

• 18 years of age or older

• Gestational age 14 weeks or greater

• Ability to provide informed consent

• Desire to proceed with outpatient D&E under moderate sedation

Exclusion Criteria:

• Contraindications to outpatient abortion or moderate sedation

• Current use of gabapentin (Neurontin®) or pregabalin (Lyrica®)

• Severe renal disease

• Allergy or sensitivity to gabapentin or pregabalin