Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/17/2019 |
Start Date: | July 28, 2018 |
End Date: | June 30, 2019 |
Contact: | Study Sponsor-Investigator, MD |
Email: | friedgp@upmc.edu |
Phone: | 412 641 3710 |
Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion: a Randomized Controlled Trial
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).
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.
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.
Inclusion Criteria:
- Women aged 18 and over
- Willing to give voluntary consent
- English-speaking
- Eligible for medication abortion per Planned Parenthood of Western Pennsylvania
protocol
- Self-reported reliable cellular phone access for the duration of study participation
- Able to receive and reply to a "test" text at time of consent
- Willing to comply with the study protocol
Exclusion Criteria:
- Use of selective serotonin reuptake inhibitors or monoamine oxidase inhibitors due to
risk of Serotonin Syndrome
- Allergy to any component of the medication abortion regimen or study drug
- Has any other condition that, in the opinion of the investigator, would preclude
informed consent, make study participation unsafe, complicate the interpretation of
the study outcome data, or otherwise interfere with achieving the study objectives
- Anticipated use of dextromethorphan during study period
We found this trial at
2
sites
Pittsburgh, Pennsylvania 15213
Phone: 412-641-5496
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Principal Investigator, MD MPH
Phone: 412-641-5496
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