Clinical trial NCT03480009: Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion
Official title: Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abortion in First Trimester
Keywords: medication abortion
dextromethorphan
pain control
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2018-03-27
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

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

Primary outcomes:
measure: Worst Pain Measurement Via Numeric Rating Scale (NRS-11)
timeFrame: Over 24 hours starting from misoprostol administration
measure: Analgesic Usage During Medication Abortion
timeFrame: Over 24 hours
Secondary outcomes:
measure: Mean Pain Scores Via Numeric Rating Scale (NRS-11)
timeFrame: Marginal mean pain scores over 24 hours
measure: Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale
timeFrame: 24 hours after misoprostol administration
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Center for Family Planning Research, Magee-Womens Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Planned Parenthood of Western Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Principal Investigator, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Penney G. Treatment of pain during medical abortion. Contraception. 2006 Jul;74(1):45-7. doi: 10.1016/j.contraception.2006.03.002. Epub 2006 May 6.
citation: Weinbroum AA, Rudick V, Paret G, Ben-Abraham R. The role of dextromethorphan in pain control. Can J Anaesth. 2000 Jun;47(6):585-96. doi: 10.1007/BF03018952.
citation: Ilkjaer S, Nielsen PA, Bach LF, Wernberg M, Dahl JB. The effect of dextromethorphan, alone or in combination with ibuprofen, on postoperative pain after minor gynaecological surgery. Acta Anaesthesiol Scand. 2000 Aug;44(7):873-7. doi: 10.1034/j.1399-6576.2000.440715.x.
citation: Christie A, Dagfinrud H, Dale O, Schulz T, Hagen KB. Collection of patient-reported outcomes;--text messages on mobile phones provide valid scores and high response rates. BMC Med Res Methodol. 2014 Apr 16;14:52. doi: 10.1186/1471-2288-14-52.
citation: Practice bulletin no. 143: medical management of first-trimester abortion. Obstet Gynecol. 2014 Mar;123(3):676-692. doi: 10.1097/01.AOG.0000444454.67279.7d.