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

Abortion in First Trimester Clinical Trial

— DexMab  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480009
• Other study ID #: STUDY19020221
• Status: Completed
• Phase: Phase 3
• Start date: July 28, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion in First Trimester

Intervention

Drug:
• Dextromethorphan Hydrobromide
Dextromethorphan capsule
• Avicel PH101 (Microcrystalline Cellulose NF) for Compounding
Placebo capsule
• Oxycodone
Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.

Locations

Country	Name	City	State
United States	Center for Family Planning Research, Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	Planned Parenthood of Western Pennsylvania	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Study Investigator-Sponsor	Society of Family Planning

Country where clinical trial is conducted

United States, 

References & Publications (5)

American College of Obstetricians and Gynecologists. Practice bulletin no. 143: medical management of first-trimester abortion. Obstet Gynecol. 2014 Mar;123(3):676-92. doi: 10.1097/01.AOG.0000444454.67279.7d. — View Citation

Christie A, Dagfinrud H, Dale Ø, 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. — View 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. — View Citation

Penney G. Treatment of pain during medical abortion. Contraception. 2006 Jul;74(1):45-7. Epub 2006 May 6. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worst Pain Measurement Via Numeric Rating Scale (NRS-11)	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".	Over 24 hours starting from misoprostol administration
Primary	Analgesic Usage During Medication Abortion	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.	Over 24 hours
Secondary	Mean Pain Scores Via Numeric Rating Scale (NRS-11)	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".	Marginal mean pain scores over 24 hours
Secondary	Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale	Overall satisfaction with pain control, "4" being - "Very good" and "1" being "Very bad"	24 hours after misoprostol administration