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CompletedPhase 4Results posted

Ketamine Versus Fentanyl for Surgical Abortions

NCT04871425 · University of Washington

Closed to entry
Status
Not accepting participants
Phase 4
Phase
110
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Satisfaction With Anesthesia Assessed by the ISAS

    Measured over At discharge or 30 minutes after the procedure

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

14 Years
Ages
FEMALE
Sex
Accepted
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

Where

1 study site

FacilityCityRegionCountry
Cedar River ClinicRentonWashingtonUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT04871425 on ClinicalTrials.gov →

Last updated in the registry 2022-03-24. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits