Abortion in First TrimesterPhase 4NCT04871425
Ketamine Versus Fentanyl for Surgical Abortions
A Phase 4 study testing Ketamine and Fentanyl in people with Abortion in First Trimester and Pain, Procedural, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion in First Trimester, Pain, Procedural, Opioid Use
- What is being tested?
- Ketamine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 14 Oct 2021
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Requesting a specific pain regimen
- Premedication with misoprostol
- Contraindications or allergies to ketamine or fentanyl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ketamine Versus Fentanyl for Surgical Abortions: A Randomized Controlled Noninferiority Trial
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.
Read the 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.
- Conditions
- Abortion in First Trimester, Pain, Procedural, Opioid Use
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At discharge or 30 minutes after the procedure
Secondary outcomes (3)
Provider Satisfaction With Anesthesia Assessed by the VAS
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.
Measured: Immediately postoperatively
Number of Participants Administered Additional Pain Medications
After the procedure, research personnel will ask anesthetist what medications, if any, they gave outside of the study protocol
Measured: Immediately postoperatively
Postoperative Pain Assessed by the VAS
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.
Measured: 24 hours postoperatively and 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start27 Apr 2021
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abortion in First TrimesterStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Jennifer Chin, University of Washington
- Investigators
- Jennifer Chin, MD, Principal investigator, Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871425
- Sponsor's protocol ID
- STUDY00012218
- Status last verified
- Mar 2022
- First submitted
- 26 Apr 2021
- Last updated
- 24 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35926204