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NCT Number: NCT04871425

Ketamine Versus Fentanyl for Surgical Abortions

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.

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Key information

Conditions

Abortion in First Trimester Neurologic Manifestations Opioid Use Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cedar River Clinic

Renton, Washington, 98057, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

IV ketamine

Fentanyl

Drug

IV fentanyl

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

Ketamine Versus Fentanyl for Surgical Abortions: A Randomized Controlled Noninferiority Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 4, 2021
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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