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Intravenous Ketamine for Pain Control During First Trimester Surgical Abortion

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ClinicalTrials.gov Identifier: NCT03751423
Recruitment Status : Not yet recruiting
First Posted : November 22, 2018
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Marie Eve Sophie Bussiere-Cote, Queen's University

Brief 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.


Condition or disease Intervention/treatment Phase
Abortion in First Trimester Drug: PO Morphine Drug: IV Fentanyl Drug: IV Ketamine Drug: PO Placebo Drug: IV Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will be a randomized, controlled, double-blinded, single-centre superiority trial with three parallel groups.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: Intravenous Ketamine for Pain Control During First Trimester Surgical Abortion
Estimated Study Start Date : April 21, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PO Morphine & IV Placebo
One third of study participants will be randomized to this local standard of care arm.
Drug: PO Morphine
10-20mg oral morphine depending on such factors as weight (100-200mcg/kg), previous opiate exposure (opiate naïve vs opiate sensitized), and participant's previous experiences with opiate medications for painful procedures. Dosing will be determined at the discretion of the surgical provider in clinic that day, as per standard of care.
Other Name: Morphine Sulphate

Drug: IV Placebo
This normal saline will be administered to the participants randomized to the oral morphine group during the procedure in the same manner that IV fentanyl or IV ketamine would be administered.
Other Name: Normal Saline

Active Comparator: IV Fentanyl & PO Placebo
One third of study participants will be randomized to this current gold standard of care arm.
Drug: IV Fentanyl
0.5-1mcg/kg IV fentanyl over 2 minutes repeated every 5 minutes as needed until appropriate analgesia is reached.
Other Name: Fentanyl Citrate Injection

Drug: PO Placebo
A standard placebo pill, the same size, shape and colour of the oral morphine. The placebo will be administered to the participants randomized to the IV ketamine and IV fentanyl during pre-op in the same manner the oral morphine would be administered.
Other Name: Oral Placebo Pill

Experimental: IV Ketamine & PO Placebo
One third of study participants will be randomized to this experimental arm.
Drug: IV Ketamine
200-500mcg/kg IV over 2 minutes repeated every 5 minutes as needed until appropriate analgesia is reached
Other Name: Ketamine Hydrochloride Injection

Drug: PO Placebo
A standard placebo pill, the same size, shape and colour of the oral morphine. The placebo will be administered to the participants randomized to the IV ketamine and IV fentanyl during pre-op in the same manner the oral morphine would be administered.
Other Name: Oral Placebo Pill




Primary Outcome Measures :
  1. VAS Pain Score - Immediate Post-Procedure [ Time Frame: 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.


Secondary Outcome Measures :
  1. VAS Pain Score - Prior to Discharge [ Time Frame: Prior to discharge from recovery room on day of procedure (typically within 1h post-procedure) ]
    This secondary outcome will post-operative pain prior to discharge 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.

  2. Length of Stay in Recovery [ Time Frame: Day of Procedure ]
    Length of stay in recovery in minutes from transfer from the procedure room till discharge.

  3. Satisfaction with Pain Control - Prior to Discharge [ Time Frame: Prior to discharge from recovery room on day of procedure (typically within 1h post-procedure) ]
    Satisfaction with pain control will be assessed using a 5-point Likert scale. 1 is the worst score and 5 is the best.

  4. Medication Side Effects [ Time Frame: Prior to discharge from recovery room on day of procedure (typically within 1h post-procedure) ]
    Medication side effects from administration till discharge as reported by the care providers and nurses.

  5. Provider Assessment of Intra-Operative Pain Management [ Time Frame: Intra-Operative ]
    Provider assessment of intra-operative pain will be reported using a 5-point Likert scale. 1 is the worst score and 5 is the best.

  6. Wong-Baker Faces Pain Score - Immediate Post-Procedure [ Time Frame: Immediate Post-Procedure ]
    Pain score will immediate post-procedure will also be reported using the Wong-Baker Faces Pain Rating Scale.

  7. Wong-Baker Faces Pain Score - Prior to Discharge [ Time Frame: Prior to discharge from recovery room on day of procedure (typically within 1h post-procedure) ]
    Pain score will prior to discharge will also be reported using the Wong-Baker Faces Pain Rating Scale.

  8. Pain Control After Discharge [ Time Frame: 2-4 weeks post-procedure ]
    Pain control after discharge will be assessed via telephone questionnaire using a 5-point Likert scale. 1 is the worst score and 5 is the best.

  9. Satisfaction with Pain Control After Discharge [ Time Frame: 2-4 weeks post-procedure ]
    Satisfaction with pain control after discharge will be assessed via telephone questionnaire using a 5-point Likert scale.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Unwanted pregnancy and consented to undergo a first trimester surgical abortion

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751423


Contacts
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Contact: Jessica Pudwell, MPH 613-549-6666 ext 3937 jessica.pudwell@queensu.ca
Contact: Heather Ramshaw, BSc 613-548-1372 ramshawh@queensu.ca

Locations
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Canada, Ontario
Queen's University Not yet recruiting
Kingston, Ontario, Canada, K7L2V7
Contact: Jessica Pudwell, MPH    613-549-6666 ext 3937    jessica.pudwell@queensu.ca   
Sponsors and Collaborators
Queen's University
Investigators
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Principal Investigator: Sophie Bussiere-Cote, MD Queen's University
Principal Investigator: Ashley Waddington, MD, MPA Queen's University

Publications:
Induced abortions reported in Canada in 2016. Ottawa: Canadian Institute for Health Information; 2018. Available at: https://www.cihi.ca/en/induced-abortions-reported-in-canada-in-2016. Accessed on July 29, 2018.

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Responsible Party: Dr. Marie Eve Sophie Bussiere-Cote, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT03751423     History of Changes
Other Study ID Numbers: OBGY-KET-18
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Marie Eve Sophie Bussiere-Cote, Queen's University:
procedural sedation
ketamine
fentanyl
morphine

Additional relevant MeSH terms:
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Morphine
Fentanyl
Ketamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia