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Ketamine Versus Fentanyl for Surgical Abortions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04871425
Recruitment Status : Completed
First Posted : May 4, 2021
Results First Posted : March 24, 2022
Last Update Posted : March 24, 2022
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Jennifer Chin, University of Washington

Tracking Information
First Submitted Date  ICMJE April 26, 2021
First Posted Date  ICMJE May 4, 2021
Results First Submitted Date  ICMJE February 3, 2022
Results First Posted Date  ICMJE March 24, 2022
Last Update Posted Date March 24, 2022
Actual Study Start Date  ICMJE April 27, 2021
Actual Primary Completion Date October 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2022)
Satisfaction With Anesthesia Assessed by the ISAS [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2021)
Satisfaction with anesthesia [ Time Frame: 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 level of postoperative pain on a 100mm visual analog scale and have the participant complete the Iowa Satisfaction with Anesthesia Scale.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2022)
  • Provider Satisfaction With Anesthesia Assessed by the VAS [ Time Frame: 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.
  • Number of Participants Administered Additional Pain Medications [ Time Frame: Immediately postoperatively ]
    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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2021)
  • Provider satisfaction with anesthesia [ Time Frame: Immediately postoperatively ]
    After the procedure, research personnel will assess provider's satisfaction with patient's anesthesia on a 100mm visual analog scale.
  • Additional pain medications necessary [ Time Frame: Immediately postoperatively ]
    After the procedure, research personnel will ask anesthetist what medications, if any, they gave outside of the study protocol
  • Postoperative pain [ Time Frame: 24 hours postoperatively and 7 days postoperatively ]
    Patients will complete 2 followup surveys asking about their postoperative pain after discharge.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Versus Fentanyl for Surgical Abortions
Official Title  ICMJE Ketamine Versus Fentanyl for Surgical Abortions: A Randomized Controlled Noninferiority Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Abortion in First Trimester
  • Pain, Procedural
  • Opioid Use
Intervention  ICMJE
  • Drug: Ketamine
    IV ketamine
  • Drug: Fentanyl
    IV fentanyl
Study Arms  ICMJE
  • 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.
    Intervention: Drug: 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.
    Intervention: Drug: Fentanyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2022)
110
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2021)
84
Actual Study Completion Date  ICMJE October 14, 2021
Actual Primary Completion Date October 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04871425
Other Study ID Numbers  ICMJE STUDY00012218
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Jennifer Chin, University of Washington
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Washington
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Society of Family Planning
Investigators  ICMJE
Principal Investigator: Jennifer Chin, MD Fellow
PRS Account University of Washington
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP