Ketamine Versus Fentanyl for Surgical Abortions

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT04871425
Collaborator
Society of Family Planning (Other)
110
1
2
5.6
19.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ketamine Versus Fentanyl for Surgical Abortions: A Randomized Controlled Noninferiority Trial
Actual Study Start Date :
Apr 27, 2021
Actual Primary Completion Date :
Oct 14, 2021
Actual Study Completion Date :
Oct 14, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ketamine

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.

Drug: Ketamine
IV ketamine

Active Comparator: Fentanyl

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.

Drug: Fentanyl
IV fentanyl

Outcome Measures

Primary Outcome Measures

  1. Satisfaction With Anesthesia Assessed by the ISAS [At discharge or 30 minutes after the procedure]

    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

  1. Provider Satisfaction With Anesthesia Assessed by the VAS [Immediately postoperatively]

    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.

  2. Number of Participants Administered Additional Pain Medications [Immediately postoperatively]

    After the procedure, research personnel will ask anesthetist what medications, if any, they gave outside of the study protocol

  3. Postoperative Pain Assessed by the VAS [24 hours postoperatively and 7 days postoperatively]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cedar River Clinic Renton Washington United States 98057

Sponsors and Collaborators

  • University of Washington
  • Society of Family Planning

Investigators

  • Principal Investigator: Jennifer Chin, MD, Fellow

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Jennifer Chin, Fellow, Family Planning: School of Medicine, University of Washington
ClinicalTrials.gov Identifier:
NCT04871425
Other Study ID Numbers:
  • STUDY00012218
First Posted:
May 4, 2021
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Ketamine Fentanyl
Arm/Group 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. Ketamine: IV ketamine 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. Fentanyl: IV fentanyl
Period Title: Overall Study
STARTED 57 53
COMPLETED 42 45
NOT COMPLETED 15 8

Baseline Characteristics

Arm/Group Title Fentanyl Ketamine Total
Arm/Group Description Participant will receive 2mg IV midazolam and 0.2-0.5mg/kg IV fentanyl over 2 minutes, which can be repeated q5 minutes until appropriate analgesia is achieved. Fentanyl: IV fentanyl Participant will receive 2mg IV midazolam and 0.5-1mcg/kg IV ketamine over 2 minutes, which can be repeated q5m until appropriate analgesia is achieved. Ketamine: IV ketamine Total of all reporting groups
Overall Participants 53 52 105
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
27.5
(6.4)
27.6
(5.8)
27.6
(6.3)
Sex: Female, Male (Count of Participants)
Female
53
100%
52
100%
105
100%
Male
0
0%
0
0%
0
0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
10
18.9%
10
19.2%
20
19%
Not Hispanic or Latino
43
81.1%
42
80.8%
85
81%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
1
1.9%
1
1%
Asian
3
5.7%
3
5.8%
6
5.7%
Native Hawaiian or Other Pacific Islander
1
1.9%
0
0%
1
1%
Black or African American
14
26.4%
7
13.5%
21
20%
White
17
32.1%
24
46.2%
41
39%
More than one race
7
13.2%
4
7.7%
11
10.5%
Unknown or Not Reported
11
20.8%
13
25%
24
22.9%
Gestational age (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]
6.4
(1.8)
7.4
(2.3)
6.7
(2)

Outcome Measures

1. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
We randomized 110 participants: 57 in the ketamine group and 53 in the fentanyl group. After randomization, an additional five participants in the ketamine group were excluded due to two participants receiving the wrong medication, one participant not achieving IV access, one not having transportation, and one being hypertensive. Thus, 52 participants received ketamine and 53 participants received fentanyl.
Arm/Group Title Ketamine Fentanyl
Arm/Group 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. Ketamine: IV ketamine 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. Fentanyl: IV fentanyl
Measure Participants 52 53
Mean (Standard Deviation) [score on a scale]
2.4
(0.8)
2.2
(0.9)
2. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Fentanyl
Arm/Group 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. Ketamine: IV ketamine 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. Fentanyl: IV fentanyl
Measure Participants 52 53
Mean (Standard Deviation) [score on a scale]
90
(15.8)
86.8
(21.3)
3. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
We randomized 110 participants: 57 in the ketamine group and 53 in the fentanyl group. After randomization, an additional five participants in the ketamine group were excluded due to two participants receiving the wrong medication, one participant not achieving IV access, one not having transportation, and one being hypertensive. Thus, 52 participants received ketamine and 53 participants received fentanyl.
Arm/Group Title Ketamine Fentanyl
Arm/Group 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. Ketamine: IV ketamine 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. Fentanyl: IV fentanyl
Measure Participants 52 53
Count of Participants [Participants]
23
43.4%
30
57.7%
4. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
We randomized 110 participants: 57 in the ketamine group and 53 in the fentanyl group. After randomization, an additional five participants in the ketamine group were excluded due to two participants receiving the wrong medication, one participant not achieving IV access, one not having transportation, and one being hypertensive. Thus, 52 participants received ketamine and 53 participants received fentanyl.
Arm/Group Title Ketamine Fentanyl
Arm/Group 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. Ketamine: IV ketamine 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. Fentanyl: IV fentanyl
Measure Participants 52 53
Pain post-op day 1
24.5
(24.2)
22
(23)
Pain post-op day 7
18.2
(21)
19.1
(27.1)

Adverse Events

Time Frame 1 week after procedure
Adverse Event Reporting Description We randomized 110 participants: 57 in the ketamine group and 53 in the fentanyl group. After randomization, an additional five participants in the ketamine group were excluded due to two participants receiving the wrong medication, one participant not achieving IV access, one not having transportation, and one being hypertensive. Thus, 52 participants received ketamine and 53 participants received fentanyl.
Arm/Group Title Ketamine Fentanyl
Arm/Group 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. Ketamine: IV ketamine 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. Fentanyl: IV fentanyl
All Cause Mortality
Ketamine Fentanyl
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/52 (0%) 0/53 (0%)
Serious Adverse Events
Ketamine Fentanyl
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/52 (0%) 0/53 (0%)
Other (Not Including Serious) Adverse Events
Ketamine Fentanyl
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/52 (0%) 0/53 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Complex Family Planning Division
Organization University of Washington
Phone 206.221.9074
Email uwfp@uw.edu
Responsible Party:
Jennifer Chin, Fellow, Family Planning: School of Medicine, University of Washington
ClinicalTrials.gov Identifier:
NCT04871425
Other Study ID Numbers:
  • STUDY00012218
First Posted:
May 4, 2021
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022