Intravenous Ketamine for Pain Control During First Trimester Surgical Abortion
Status:
Suspended
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Dr. Marie Eve Sophie Bussiere-Cote Queen's University