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临床试验/NCT03480009
NCT03480009已完成3 期

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

Study Investigator-Sponsor2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2018年7月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
156
试验地点
2
主要终点
Worst Pain Measurement Via Numeric Rating Scale (NRS-11)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Dextromethorphan, opted for narcotic prescription

Experimental

Dextromethorphan hydrobromide and patient opts for narcotics (oxycodone or other standard narcotics)

干预措施: Dextromethorphan Hydrobromide (Drug)

Dextromethorphan, opted for narcotic prescription

Experimental

Dextromethorphan hydrobromide and patient opts for narcotics (oxycodone or other standard narcotics)

干预措施: Oxycodone (Drug)

Placebo, opted for narcotic prescription

Placebo Comparator

Avicel PH101 (Microcrystalline Cellulose NF) and patient opts for narcotics (oxycodone or other standard narcotics)

干预措施: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding (Drug)

Placebo, opted for narcotic prescription

Placebo Comparator

Avicel PH101 (Microcrystalline Cellulose NF) and patient opts for narcotics (oxycodone or other standard narcotics)

干预措施: Oxycodone (Drug)

Dextromethorphan, declined narcotic prescription

Experimental

Dextromethorphan hydrobromide and patient declines narcotic

干预措施: Dextromethorphan Hydrobromide (Drug)

Placebo, declined narcotic prescription

Placebo Comparator

Avicel PH101 (Microcrystalline Cellulose NF) for Compounding and patient declines narcotic

干预措施: Avicel PH101 (Microcrystalline Cellulose NF) for Compounding (Drug)

结局指标

主要结局

Worst Pain Measurement Via Numeric Rating Scale (NRS-11)

时间窗: 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

时间窗: 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.

次要结局

  • Number of Participants With Pain Control Satisfaction Via 4-pt Likert Scale(24 hours after misoprostol administration)
  • Mean Pain Scores Via Numeric Rating Scale (NRS-11)(Marginal mean pain scores over 24 hours)

研究者

发起方
Study Investigator-Sponsor
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Study Investigator-Sponsor

Associate Professor

University of Pittsburgh

研究点 (2)

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