Trial Outcomes & Findings for Ketamine Versus Fentanyl for Surgical Abortions (NCT NCT04871425)

Last Updated: 2022-03-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

110 participants

Primary outcome timeframe

At discharge or 30 minutes after the procedure

Results posted on

2022-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine 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. Ketamine: IV ketamine	Fentanyl 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. Fentanyl: IV fentanyl
Overall Study STARTED	57	53
Overall Study COMPLETED	42	45
Overall Study NOT COMPLETED	15	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ketamine Versus Fentanyl for Surgical Abortions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fentanyl n=53 Participants Participant will receive 2mg IV midazolam and 0.2-0.5mg/kg IV fentanyl over 2 minutes, which can be repeated q5 minutes until appropriate analgesia is achieved. Fentanyl: IV fentanyl	Ketamine n=52 Participants Participant will receive 2mg IV midazolam and 0.5-1mcg/kg IV ketamine over 2 minutes, which can be repeated q5m until appropriate analgesia is achieved. Ketamine: IV ketamine	Total n=105 Participants Total of all reporting groups
Age, Continuous	27.5 years STANDARD_DEVIATION 6.4 • n=5 Participants	27.6 years STANDARD_DEVIATION 5.8 • n=7 Participants	27.6 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	52 Participants n=7 Participants	105 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants	42 Participants n=7 Participants	85 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	24 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Gestational age	6.4 weeks STANDARD_DEVIATION 1.8 • n=5 Participants	7.4 weeks STANDARD_DEVIATION 2.3 • n=7 Participants	6.7 weeks STANDARD_DEVIATION 2 • n=5 Participants

PRIMARY outcome

Timeframe: At discharge or 30 minutes after the procedure

Population: We randomized 110 participants: 57 in the ketamine group and 53 in the fentanyl group. After randomization, an additional five participants in the ketamine group were excluded due to two participants receiving the wrong medication, one participant not achieving IV access, one not having transportation, and one being hypertensive. Thus, 52 participants received ketamine and 53 participants received fentanyl.

Outcome measures

Outcome measures
Measure	Ketamine n=52 Participants 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. Ketamine: IV ketamine	Fentanyl n=53 Participants 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. Fentanyl: IV fentanyl
Satisfaction With Anesthesia Assessed by the ISAS	2.4 score on a scale Standard Deviation 0.8	2.2 score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ketamine n=52 Participants 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. Ketamine: IV ketamine	Fentanyl n=53 Participants 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. Fentanyl: IV fentanyl
Provider Satisfaction With Anesthesia Assessed by the VAS	90 score on a scale Standard Deviation 15.8	86.8 score on a scale Standard Deviation 21.3

SECONDARY outcome

Timeframe: Immediately postoperatively

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

Outcome measures

Outcome measures
Measure	Ketamine n=52 Participants 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. Ketamine: IV ketamine	Fentanyl n=53 Participants 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. Fentanyl: IV fentanyl
Number of Participants Administered Additional Pain Medications	23 Participants	30 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ketamine n=52 Participants 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. Ketamine: IV ketamine	Fentanyl n=53 Participants 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. Fentanyl: IV fentanyl
Postoperative Pain Assessed by the VAS Pain post-op day 1	24.5 score on a scale Standard Deviation 24.2	22 score on a scale Standard Deviation 23
Postoperative Pain Assessed by the VAS Pain post-op day 7	18.2 score on a scale Standard Deviation 21	19.1 score on a scale Standard Deviation 27.1

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fentanyl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Complex Family Planning Division

University of Washington

Phone: 206.221.9074

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place