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:
Exclusion Criteria:
|
Interventions | "Drug: Dextromethorphan Hydrobromide Dextromethorphan capsule Other Name: Robitussin, Delsym
Placebo capsule Other Name: Avicel
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 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".
Overall satisfaction with pain control, "4" being ‐ "Very good" and "1" being "Very bad"" |
Notes |