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Phase 3 Completed N=156 Randomized Quadruple-blind Treatment

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

Abortion in First Trimester
Source: ClinicalTrials.gov NCT03480009 ↗
Enrolled (actual)
156
Serious AEs
0.6%
Results posted
Aug 2020
Primary outcomePrimary: Worst Pain Measurement Via Numeric Rating Scale (NRS-11) — 8.0; 7.0; 7.5; 6.5 score on a scale — p=.20
◆ Published Evidence
Emerging
4citations · ~1 / year
Dextromethorphan as a novel nonopioid adjunctive agent for pain control with medication abortion: A randomized controlled trial.
Contraception · 2023 · Likely link

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).

Linked Publications

  • Dextromethorphan as a novel nonopioid adjunctive agent for pain control with medication abortion: A randomized controlled trial.
    Contraception · 2023 · 4 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Worst Pain Measurement Via Numeric Rating Scale (NRS-11)
8.0; 7.0; 7.5; 6.5 .20
PRIMARY
Analgesic Usage During Medication Abortion
800; 600; 800; 1000; 1000; 1300 .81
SECONDARY
Mean Pain Scores Via Numeric Rating Scale (NRS-11)
2.93; 2.96; 2.70; 2.41 .99
SECONDARY
Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale
3; 0; 0; 0; 11; 4 .07

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03480009) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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