This study evaluates dextromethorphan as a non-opioid adjunctive medication for pain control during medication abortion. This is double-blinded, four-arm randomized controlled trial enrolling 156 women over a period of 9-12 months: Receiving narcotics+dextromethorphan, narcotics and placebo (microcrystalline cellulose), no narcotics and dextromethorphan and no narcotics and placebo (microcrystalline cellulose).
Medication abortion using mifepristone and misoprostol is common, accounting for nearly one-third of abortions in the United States in 2014. Although women generally tolerate medical abortion well, pain and bleeding are common and expected side effects. Up to a quarter of women rate their pain as severe during their procedure. Pain management for medical abortion is challenging given that the most acute pain occurs at home rather than under the supervision of medical professionals. Currently there is insufficient evidence to recommend an optimal regimen for pain control in medication abortion and there are concerns surrounding narcotic prescribing and the opiate abuse epidemic. This is a four-arm, prospective, double-blind, randomized controlled trial comparing dextromethorphan administration in conjunction with the current standard regimen (NSAIDs and narcotic medication by request- commonly oxycodone or codeine) to the standard regimen alone. Pain will be evaluated by analgesia usage and self-reported pain scores. Investigators will also investigate factors influencing pain and subjective components of the patient narrative. Ideally, a non-opioid adjunct to NSAIDs or narcotics could be used to control pain and significantly curtail or avoid opioid use. Investigators seek to test the efficacy and safety of dextromethorphan as a non-narcotic analgesic for medication abortion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
Dextromethorphan capsule
Placebo capsule
Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.
Center for Family Planning Research, Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Planned Parenthood of Western Pennsylvania
Pittsburgh, Pennsylvania, United States
Worst Pain Measurement Via Numeric Rating Scale (NRS-11)
Self-reported pain measurement via text-messaging system during first 24 hours after misoprostol administration. The scale is from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible".
Time frame: Over 24 hours starting from misoprostol administration
Analgesic Usage During Medication Abortion
Analgesic usage by study arm for women who received dextromethorphan vs. placebo as adjunct to routine pain management during medication abortion; missing data are for participants who did not take the specified pain medication.
Time frame: Over 24 hours
Mean Pain Scores Via Numeric Rating Scale (NRS-11)
Marginal mean pain scores via Numeric Rating Scale (NRS-11) over 24 hours. The scale is from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible".
Time frame: Marginal mean pain scores over 24 hours
Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale
Overall satisfaction with pain control, "4" being - "Very good" and "1" being "Very bad"
Time frame: 24 hours after misoprostol administration
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