NCT04871425

Ketamine Versus Fentanyl for Surgical Abortions

Completed Phase 4 Results posted Last updated 24 March 2022

What this trial tests

Phase 4 trial testing Ketamine in Abortion in First Trimester in 110 participants. Completed in 14 October 2021.

Timeline

27 April 2021

Primary endpoint
14 October 2021

14 October 2021

Quick facts

Lead sponsor	University of Washington
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	110
Start date	27 April 2021
Primary completion	14 October 2021
Estimated completion	14 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Ketamine (ketamine) — full drug profile →
• Fentanyl (fentanyl) — full drug profile →

Conditions studied

• Abortion in First Trimester — all drugs for Abortion in First Trimester →
• Pain, Procedural — all drugs for Pain, Procedural →
• Opioid Use — all drugs for Opioid Use →

Sponsor

University of Washington

Who can join

14 and older, female only, with Abortion in First Trimester or Pain, Procedural. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Satisfaction With Anesthesia Assessed by the ISAS Primary · 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.

Group	Value	95% CI
Ketamine	2.4	± 0.8
Fentanyl	2.2	± 0.9

Provider Satisfaction With Anesthesia Assessed by the VAS Secondary · 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.

Group	Value	95% CI
Ketamine	90	± 15.8
Fentanyl	86.8	± 21.3

Number of Participants Administered Additional Pain Medications Secondary · Immediately postoperatively

After the procedure, research personnel will ask anesthetist what medications, if any, they gave outside of the study protocol

Group	Value	95% CI
Ketamine	23
Fentanyl	30

Postoperative Pain Assessed by the VAS Secondary · 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.

Pain post-op day 1

Group	Value	95% CI
Ketamine	24.5	± 24.2
Fentanyl	22	± 23

Pain post-op day 7

Group	Value	95% CI
Ketamine	18.2	± 21
Fentanyl	19.1	± 27.1

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ketamine Compared With Fentanyl for Surgical Abortion: A Randomized Controlled Trial.
   Chin J, McGrath M, Lokken E, Upegui CD, et al · · 2022 · cited 6× · PMID 35926204 · DOI 10.1097/aog.0000000000004903