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. 2022 May 13;2022(5):CD013525. doi: 10.1002/14651858.CD013525.pub2

NCT03480009.

Methods "Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment"
Participants "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"

Interventions "Drug: Dextromethorphan Hydrobromide
Dextromethorphan capsule
Other Name: Robitussin, Delsym
  • Drug: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding


Placebo capsule
Other Name: Avicel
  • Drug: Oxycodone


Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.
Other Name: Tylox, Percodan, OxyContin"
Outcomes Primary outcomes: "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".
  • 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: "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".
  • 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""
Notes