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Ketamine Versus Fentanyl for Surgical Abortions

Primary Purpose

Abortion in First Trimester, Pain, Procedural, Opioid Use

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Fentanyl
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abortion in First Trimester

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 14 years or older
  • Voluntarily requesting surgical pregnancy termination
  • Intrauterine pregnancy up to 13 weeks 6 days by transabdominal or transvaginal ultrasound performed on day of procedure
  • Eligible for suction curettage
  • English or Spanish speaking
  • Able and willing to give informed consent and agree to terms of the study

Exclusion Criteria:

  • Age less than 14 years
  • Reaspiration procedure or failed medication abortion
  • Early pregnancy loss
  • Alcohol use disorder or acute alcohol intoxication
  • Currently incarcerated
  • Gestational age 14 weeks or more
  • Requesting a specific pain regimen
  • Premedication with misoprostol
  • Contraindications or allergies to ketamine or fentanyl

Sites / Locations

  • Cedar River Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketamine

Fentanyl

Arm Description

Participant will receive 2mg IV midazolam and 0.2-0.5mg/kg IV ketamine over 2 minutes, which can be repeated q5 minutes until appropriate analgesia is achieved.

Participant will receive 2mg IV midazolam and 0.5-1mcg/kg IV fentanyl over 2 minutes, which can be repeated q5m until appropriate analgesia is achieved.

Outcomes

Primary Outcome Measures

Satisfaction With Anesthesia Assessed by the ISAS
After the procedure, either at time of discharge (if less than 30 minutes) or at 30 minutes (if not yet discharged), research personnel will assess the participant's satisfaction with anesthesia using the Iowa Satisfaction with Anesthesia Scale. This is a validated perioperative anesthesia satisfaction scale with a minimum score of -3 and a maximum score of +3 with higher scores indicating higher satisfaction.

Secondary Outcome Measures

Provider Satisfaction With Anesthesia Assessed by the VAS
After the procedure, research personnel will assess provider's satisfaction with patient's anesthesia on a 100mm visual analog scale. The minimum score is 0mm and the maximum score if 100mm, with higher scores indicating higher satisfaction.
Number of Participants Administered Additional Pain Medications
After the procedure, research personnel will ask anesthetist what medications, if any, they gave outside of the study protocol
Postoperative Pain Assessed by the VAS
Patients will complete 2 followup surveys asking about their postoperative pain after discharge. This will be assessed on a 100mm visual analog scale. The minimum score is 0mm and the maximum score if 100mm, with higher scores indicating higher pain levels.

Full Information

First Posted
April 26, 2021
Last Updated
March 22, 2022
Sponsor
University of Washington
Collaborators
Society of Family Planning
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1. Study Identification

Unique Protocol Identification Number
NCT04871425
Brief Title
Ketamine Versus Fentanyl for Surgical Abortions
Official Title
Ketamine Versus Fentanyl for Surgical Abortions: A Randomized Controlled Noninferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
October 14, 2021 (Actual)
Study Completion Date
October 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Society of Family Planning

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Ketamine is commonly used for procedural sedation and analgesia. It is widely used for trauma cases in the emergency department and is considered a superior agent in the outpatient setting due to its lack of respiratory and cardiovascular depression. In chronic opioid users, ketamine decreases acute pain and reduces postoperative opioid consumption. Few studies have examined the use of ketamine for surgical abortions. Previous studies found significant rates of emergence phenomena; however, this can be prevented if a benzodiazepine is given at the same time. Ketamine deserves further study to determine whether it is an acceptable alternative to a standard opioid-based regimen for surgical abortion. Our primary objective is to compare patient satisfaction after surgical abortion among patients receiving IV ketamine versus IV fentanyl for procedural sedation. Our secondary objectives include postoperative pain, additional pain medication used, and postoperative opioid use after the procedure. Our hypothesis is that ketamine will provide similar patient satisfaction and reduce postoperative opioid use. This will be a randomized controlled noninferiority clinical trial of 84 women receiving either IV ketamine with IV midazolam or IV fentanyl with IV midazolam for outpatient one day surgical abortions up to 13, 6/7 weeks gestation. Both groups will receive a standardized paracervical block and additional pain medication as needed. Our study has the potential to introduce IV ketamine as a satisfactory medication for outpatient surgical abortions. Ketamine may decrease the need for IV fentanyl, reduce postoperative opioid use, and may prove to be a superior analgesic for chronic opioid users.
Detailed Description
First-trimester surgical abortions are one of the most common outpatient procedures worldwide. Although abortion is a quick procedure, most patients still report at least moderate pain.1 Most providers use a paracervical block plus intravenous (IV) moderate sedation with fentanyl (38%) or oral medication (33%). A recent trial comparing IV fentanyl to placebo among participants who also received the paracervical block found a 1-point difference in pain on an 11-point scale. The authors questioned the benefit of this reduction in pain in light of fentanyl's various side effects including nausea and drowsiness, the requirement for additional monitoring and resuscitative equipment, and need for naloxone in case of overdose. Due to our nation's opioid crisis, there has been growing interest in identifying a non-opioid medication to provide safe, short term, satisfactory pain control during first trimester outpatient surgical abortions. Ketamine is commonly used for procedural sedation and analgesia, and it also reduces postoperative pain. It acts primarily as an N-methyl-D-aspartate receptor antagonist but has some opioid receptor activity. It is widely used for trauma cases and acute pain crises, and is considered a superior agent in the outpatient setting due to its lack of respiratory and cardiovascular depression. Few studies have examined ketamine for surgical abortions. Most studies found improvement when compared to the paracervical block or remifentanil. Our study's primary outcome was to determine if ketamine was noninferior in terms of patient satisfaction with anesthesia to fentanyl for procedural sedation for outpatient first trimester surgical abortions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion in First Trimester, Pain, Procedural, Opioid Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Experimental
Arm Description
Participant will receive 2mg IV midazolam and 0.2-0.5mg/kg IV ketamine over 2 minutes, which can be repeated q5 minutes until appropriate analgesia is achieved.
Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
Participant will receive 2mg IV midazolam and 0.5-1mcg/kg IV fentanyl over 2 minutes, which can be repeated q5m until appropriate analgesia is achieved.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
IV ketamine
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
IV fentanyl
Primary Outcome Measure Information:
Title
Satisfaction With Anesthesia Assessed by the ISAS
Description
After the procedure, either at time of discharge (if less than 30 minutes) or at 30 minutes (if not yet discharged), research personnel will assess the participant's satisfaction with anesthesia using the Iowa Satisfaction with Anesthesia Scale. This is a validated perioperative anesthesia satisfaction scale with a minimum score of -3 and a maximum score of +3 with higher scores indicating higher satisfaction.
Time Frame
At discharge or 30 minutes after the procedure
Secondary Outcome Measure Information:
Title
Provider Satisfaction With Anesthesia Assessed by the VAS
Description
After the procedure, research personnel will assess provider's satisfaction with patient's anesthesia on a 100mm visual analog scale. The minimum score is 0mm and the maximum score if 100mm, with higher scores indicating higher satisfaction.
Time Frame
Immediately postoperatively
Title
Number of Participants Administered Additional Pain Medications
Description
After the procedure, research personnel will ask anesthetist what medications, if any, they gave outside of the study protocol
Time Frame
Immediately postoperatively
Title
Postoperative Pain Assessed by the VAS
Description
Patients will complete 2 followup surveys asking about their postoperative pain after discharge. This will be assessed on a 100mm visual analog scale. The minimum score is 0mm and the maximum score if 100mm, with higher scores indicating higher pain levels.
Time Frame
24 hours postoperatively and 7 days postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 14 years or older Voluntarily requesting surgical pregnancy termination Intrauterine pregnancy up to 13 weeks 6 days by transabdominal or transvaginal ultrasound performed on day of procedure Eligible for suction curettage English or Spanish speaking Able and willing to give informed consent and agree to terms of the study Exclusion Criteria: Age less than 14 years Reaspiration procedure or failed medication abortion Early pregnancy loss Alcohol use disorder or acute alcohol intoxication Currently incarcerated Gestational age 14 weeks or more Requesting a specific pain regimen Premedication with misoprostol Contraindications or allergies to ketamine or fentanyl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Chin, MD
Organizational Affiliation
Fellow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedar River Clinic
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35926204
Citation
Chin J, McGrath M, Lokken E, Upegui CD, Prager S, Micks E. Ketamine Compared With Fentanyl for Surgical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2022 Sep 1;140(3):461-469. doi: 10.1097/AOG.0000000000004903. Epub 2022 Aug 3.
Results Reference
derived

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Ketamine Versus Fentanyl for Surgical Abortions

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