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NCT Number: NCT03480009

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

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Center for Family Planning Research, Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dextromethorphan hydrobromide

Drug

Dextromethorphan capsule

Other names: Robitussin, Delsym

Avicel PH101 (Microcrystalline Cellulose NF) for Compounding

Drug

Placebo capsule

Other names: Avicel

Oxycodone

Drug

Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.

Other names: Tylox, Percodan, OxyContin

Primary outcomes

  1. Worst Pain Measurement Via Numeric Rating Scale (NRS-11)

    Time frame: 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".

  2. Analgesic Usage During Medication Abortion

    Time frame: 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 outcomes

  1. Mean Pain Scores Via Numeric Rating Scale (NRS-11)

    Time frame: 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".

  2. Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale

    Time frame: 24 hours after misoprostol administration

    Overall satisfaction with pain control, "4" being - "Very good" and "1" being "Very bad"

Sponsors and collaborators

Lead sponsor

Study Investigator-Sponsor

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

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

Acronym: DexMab

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2018
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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