Ketamine Versus Fentanyl for Surgical Abortions

NCT04871425 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00012218
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Abortion in First Trimester; Pain, Procedural; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Satisfaction With Anesthesia Assessed by the ISAS

  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.

  At discharge or 30 minutes after the procedure

Secondary Outcomes (3)

• Provider Satisfaction With Anesthesia Assessed by the VAS

  Immediately postoperatively

• Number of Participants Administered Additional Pain Medications

  Immediately postoperatively

• Postoperative Pain Assessed by the VAS

  24 hours postoperatively and 7 days postoperatively

Study Arms (2)

Ketamine

EXPERIMENTAL

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

Fentanyl

ACTIVE COMPARATOR

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

Interventions

Ketamine DRUG

IV ketamine

Ketamine

Fentanyl DRUG

IV fentanyl

Fentanyl

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Society of Family Planning: collaborator

Study Sites (1)

Cedar River Clinic

Renton, Washington, 98057, United States

Location

Related Publications (1)

• Chin J, McGrath M, Lokken E, Upegui CD, Prager S, Micks E. Ketamine Compared With Fentanyl for Surgical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2022 Sep 1;140(3):461-469. doi: 10.1097/AOG.0000000000004903. Epub 2022 Aug 3.

  PMID: 35926204 DERIVED

MeSH Terms

Conditions

Pain, Procedural

Interventions

Ketamine; Fentanyl

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Complex Family Planning Division
• Organization: University of Washington

uwfp@uw.edu

206.221.9074

Study Officials

• Jennifer Chin, MD

  Fellow

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow, Family Planning: School of Medicine

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 4, 2021
• Study Start: April 27, 2021
• Primary Completion: October 14, 2021
• Study Completion: October 14, 2021
• Last Updated: March 24, 2022
• Results First Posted: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)