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临床试验/NCT03751423
NCT03751423暂停3 期

Intravenous Ketamine for Pain Control During First Trimester Surgical Abortion

Dr. Marie Eve Sophie Bussiere-Cote1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2019年6月10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
暂停
发起方
入组人数
123
试验地点
1
主要终点
VAS Pain Score - Immediate Post-Procedure

研究概览

简要总结

A therapeutic abortion is one of the most common procedures performed in Canada, with approximately 100,000 occurring annually. 95% of induced abortions are done surgically, with just over two thirds of these procedures taking place in the first trimester.

This study will be a randomized, controlled, double-blinded, single-centre superiority trial with three parallel groups; oral morphine vs intravenous fentanyl vs intravenous ketamine. The primary outcome will be immediate post-operative pain following a first trimester therapeutic abortion as assessed using the visual analogue scale. Randomization will be performed as block randomization with a 1:1:1 allocation ratio. In total, 123 participants will be recruited and randomized, with 41 being assigned to each treatment arm. This study will be conducted at the Women's Clinic at Kingston General Hospital in Kingston, Ontario, Canada. Women from Kingston and the surrounding areas are referred to this clinic and can self-refer for therapeutic abortion.

The investogators hope that this research will move us towards a better form of pain control for our participants undergoing first trimester surgical abortion, without increasing length of stay, side effects, or adverse events. This, in turn, will hopefully improve access to optimal pain control to participants undergoing first trimester surgical abortion in an outpatient setting.

详细描述

Rationale:

At present, the gold standard for pain control during first trimester abortion is the combination of a paracervical block with moderate intravenous (IV) sedation. Paracervical blocks are routinely done with lidocaine, with or without epinephrine or vasopressin. Moderate sedation is commonly achieved using fentanyl 50-100ug IV and midazolam 1-2mg IV. The issue with the use of IV opioids for sedation is the need for continuous cardio-respiratory monitoring, due to the risk of cardio-respiratory depression or collapse. This therefore limits the ability of some centers to provide the best form of pain control for their participants undergoing first trimester surgical abortion. For instance, our center currently uses a paracervical block plus a combination of oral medications (morphine and lorazepam), which has been found to be inferior to a paracervical block plus IV sedation. All participants without contraindications to NSAIDs are pre-medicated with naproxen as recommended.2 The investigators also have access to nitrous oxide/oxygen 50:50 (Entonox) to use as an adjunct, however this has not been found to significantly improve procedural or post-operative pain.

In the past, ketamine was used for pain control during first trimester abortion. Ketamine is a dissociative agent and does not carry the same risk of cardio-respiratory depression as intravenous opioids. Ketamine was felt to be ideal for first trimester surgical abortion -as the medication has uterotonic properties, which could result in less blood loss. Doses of 0.5mg/kg IV were typically used. However, the use of ketamine for first trimester surgical abortion decreased dramatically after the 1970-1980's due to reports of adverse events including emergence phenomena (nightmares), nausea, and vomiting. In fact, only one study published during this time did not find negative emergence phenomena in participants exposed to ketamine. More recently, a systematic review concluded that ketamine was an inferior agent when compared to propofol for pain control during first trimester surgical abortion. However, propofol, a general anesthetic requiring continuous cardio-respiratory monitoring, should not be placed in the same anesthetic category as ketamine. Furthermore, propofol is only available in a limited number of settings offering first trimester surgical abortion.

Over the last 10 to 15 years, ketamine has become an increasingly commonly used dissociative agent for procedural sedation in the emergency department. The benefits of its use include the simultaneous provision of both sedation and analgesia, while maintaining airway reflexes and respiratory drive. Intravenous ketamine use in the emergency department has been shown to yield high success rates (94% to 100%). In addition, of all the drugs commonly used in this setting, ketamine has one of the highest safety profiles and lowest rates of complications.

The investigators are interested in re-visiting whether ketamine would be an appropriate choice of anesthetic for first trimester surgical abortion. If ketamine is found to be superior to IV fentanyl, it would potentially increase access to optimal pain control in settings where continuous cardio-respiratory monitoring is not available. Furthermore, in the current era of opioid misuse, it is important that providers look for alternative forms of pain management when appropriate. In fact, the Society for Family Planning recently put out a call to action for more research on alternative options to control pain short of moderate or deep sedation.

研究设计

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

盲法说明

For the three treatment arms, the nurses, the study participants, and the abortion provider will be blinded to study arm assignment and will remain blinded throughout the course of the study. As such, all study personnel who will be administering questionnaires will be appropriately blinded to minimize bias. The provider of the IV medications will not be blinded. This decision was made in order to ensure participant safety in titrating medication doses, and to avoid the need to unblind all members if a reversal agent is required. The provider of the anesthetic will not disclose which study arm the participant belongs to and will not be involved in administering questionnaires or data analysis.

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

  • Confirmed first trimester pregnancy with an ultrasound showing a viable intrauterine pregnancy with a gestational age of less than 12 weeks since the last menstrual period
  • Unwanted pregnancy and consented to undergo a first trimester surgical abortion

排除标准

  • Age <18 years at the time of study enrollment
  • Known allergy or sensitivity to any of the medications used in the study
  • Any serious medical comorbidity that would make IV sedation contraindicated in an outpatient setting (ex. Heart disease, lung disease)

研究组 & 干预措施

PO Morphine & IV Placebo

Active Comparator

One third of study participants will be randomized to this local standard of care arm.

干预措施: PO Morphine (Drug)

PO Morphine & IV Placebo

Active Comparator

One third of study participants will be randomized to this local standard of care arm.

干预措施: IV Placebo (Drug)

IV Fentanyl & PO Placebo

Active Comparator

One third of study participants will be randomized to this current gold standard of care arm.

干预措施: IV Fentanyl (Drug)

IV Fentanyl & PO Placebo

Active Comparator

One third of study participants will be randomized to this current gold standard of care arm.

干预措施: PO Placebo (Drug)

IV Ketamine & PO Placebo

Experimental

One third of study participants will be randomized to this experimental arm.

干预措施: IV Ketamine (Drug)

IV Ketamine & PO Placebo

Experimental

One third of study participants will be randomized to this experimental arm.

干预措施: PO Placebo (Drug)

结局指标

主要结局

VAS Pain Score - Immediate Post-Procedure

时间窗: Immediate Post-Procedure

The primary outcome measure is mean difference in immediate post-operative pain measured by the visual analogue pain scale (VAS). The VAS is a validated tool for research in operative pain management. Using this scale, participants rate their current pain on a scale from 0 to 10 by drawing an "x" on the horizontal line. This line is 10cm long and the participant's pain level is measured using a ruler to the millimeter mark and translated to a score out of 100mm. If the "x" falls between millimeter marks on the ruler the reader will round up to the nearest mark.

次要结局

  • Length of Stay in Recovery(Day of Procedure)
  • VAS Pain Score - Prior to Discharge(Prior to discharge from recovery room on day of procedure (typically within 1h post-procedure))
  • Provider Assessment of Intra-Operative Pain Management(Intra-Operative)
  • Pain Control After Discharge(2-4 weeks post-procedure)
  • Medication Side Effects(Prior to discharge from recovery room on day of procedure (typically within 1h post-procedure))
  • Wong-Baker Faces Pain Score - Immediate Post-Procedure(Immediate Post-Procedure)
  • Satisfaction with Pain Control - Prior to Discharge(Prior to discharge from recovery room on day of procedure (typically within 1h post-procedure))
  • Satisfaction with Pain Control After Discharge(2-4 weeks post-procedure)
  • Wong-Baker Faces Pain Score - Prior to Discharge(Prior to discharge from recovery room on day of procedure (typically within 1h post-procedure))

研究者

发起方
Dr. Marie Eve Sophie Bussiere-Cote
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Marie Eve Sophie Bussiere-Cote

Principal Investigator

Queen's University

研究点 (1)

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