Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion

Phase 3

Completed

Interventions: Drug: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding
Drug: Dextromethorphan Hydrobromide
Drug: Oxycodone

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo, declined narcotic prescription	Avicel PH101 (Microcrystalline Cellulose NF) for Compounding	Avicel PH101 (Microcrystalline Cellulose NF) for Compounding and patient declines narcotic
Placebo, opted for narcotic prescription	Avicel PH101 (Microcrystalline Cellulose NF) for Compounding	Avicel PH101 (Microcrystalline Cellulose NF) and patient opts for narcotics (oxycodone or other standard narcotics)
Dextromethorphan, opted for narcotic prescription	Dextromethorphan Hydrobromide	Dextromethorphan hydrobromide and patient opts for narcotics (oxycodone or other standard narcotics)
Dextromethorphan, opted for narcotic prescription	Oxycodone	Dextromethorphan hydrobromide and patient opts for narcotics (oxycodone or other standard narcotics)
Placebo, opted for narcotic prescription	Oxycodone	Avicel PH101 (Microcrystalline Cellulose NF) and patient opts for narcotics (oxycodone or other standard narcotics)
Dextromethorphan, declined narcotic prescription	Dextromethorphan Hydrobromide	Dextromethorphan hydrobromide and patient declines narcotic

Primary Outcome Measures

Name	Time	Method
Worst Pain Measurement Via Numeric Rating Scale (NRS-11)	Over 24 hours starting from misoprostol administration	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".
Analgesic Usage During Medication Abortion	Over 24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale	24 hours after misoprostol administration	Overall satisfaction with pain control, "4" being - "Very good" and "1" being "Very bad"
Mean Pain Scores Via Numeric Rating Scale (NRS-11)	Marginal mean pain scores over 24 hours	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".

Locations (2): Center for Family Planning Research, Magee-Womens Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Planned Parenthood of Western Pennsylvania
🇺🇸
Pittsburgh, Pennsylvania, United States