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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion: a Randomized Controlled Trial

Conditions
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Abortion in First Trimester

Intervention / Treatment
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* Drug: Dextromethorphan Hydrobromide
* Drug: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding
* Drug: Oxycodone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextromethorphan, opted for narcotic prescription<br>Dextromethorphan hydrobromide and patient opts for narcotics (oxycodone or other standard narcotics) | Drug: Dextromethorphan Hydrobromide<br>* Dextromethorphan capsule<br>* Other names: Robitussin, Delsym;Drug: Oxycodone<br>* Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.<br>* Other names: Tylox, Percodan, OxyContin;|
| Placebo Comparator: Placebo, opted for narcotic prescription<br>Avicel PH101 (Microcrystalline Cellulose NF) and patient opts for narcotics (oxycodone or other standard narcotics) | Drug: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding<br>* Placebo capsule<br>* Other names: Avicel;Drug: Oxycodone<br>* Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.<br>* Other names: Tylox, Percodan, OxyContin;|
| Experimental: Dextromethorphan, declined narcotic prescription<br>Dextromethorphan hydrobromide and patient declines narcotic | Drug: Dextromethorphan Hydrobromide<br>* Dextromethorphan capsule<br>* Other names: Robitussin, Delsym;|
| Placebo Comparator: Placebo, declined narcotic prescription<br>Avicel PH101 (Microcrystalline Cellulose NF) for Compounding and patient declines narcotic | Drug: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding<br>* Placebo capsule<br>* Other names: Avicel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Over 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 24 hours after misoprostol administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medication abortion, dextromethorphan, pain control