Ketamine Versus Fentanyl for Surgical Abortions
Condition: Abortion in First Trimester; Pain, Procedural; Opioid Use
MeSH terms: Pain, Procedural
Intervention: Ketamine; Fentanyl
Intervention description: IV ketamine; IV fentanyl
Intervention MeSH terms: Fentanyl; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: Female
Minimum age: 14 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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