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Ketamine Versus Fentanyl for Surgical Abortions

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04871425
Enrollment
110
Registered
2021-05-04
Start date
2021-04-27
Completion date
2021-10-14
Last updated
2022-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abortion in First Trimester, Opioid Use, Pain, Procedural

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.

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.

Interventions

DRUGKetamine

IV ketamine

DRUGFentanyl

IV fentanyl

Sponsors

Society of Family Planning
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction With Anesthesia Assessed by the ISASAt discharge or 30 minutes after the procedureAfter 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

MeasureTime frameDescription
Provider Satisfaction With Anesthesia Assessed by the VASImmediately postoperativelyAfter 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.
Number of Participants Administered Additional Pain MedicationsImmediately postoperativelyAfter the procedure, research personnel will ask anesthetist what medications, if any, they gave outside of the study protocol
Postoperative Pain Assessed by the VAS24 hours postoperatively and 7 days postoperativelyPatients 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Fentanyl
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
53
Ketamine
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
52
Total105

Baseline characteristics

CharacteristicFentanylKetamineTotal
Age, Continuous27.5 years
STANDARD_DEVIATION 6.4
27.6 years
STANDARD_DEVIATION 5.8
27.6 years
STANDARD_DEVIATION 6.3
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants10 Participants20 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
43 Participants42 Participants85 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Gestational age6.4 weeks
STANDARD_DEVIATION 1.8
7.4 weeks
STANDARD_DEVIATION 2.3
6.7 weeks
STANDARD_DEVIATION 2
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
3 Participants3 Participants6 Participants
Race (NIH/OMB)
Black or African American
14 Participants7 Participants21 Participants
Race (NIH/OMB)
More than one race
7 Participants4 Participants11 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants13 Participants24 Participants
Race (NIH/OMB)
White
17 Participants24 Participants41 Participants
Sex: Female, Male
Female
53 Participants52 Participants105 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 520 / 53
other
Total, other adverse events
0 / 520 / 53
serious
Total, serious adverse events
0 / 520 / 53

Outcome results

Primary

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
KetamineSatisfaction With Anesthesia Assessed by the ISAS2.4 score on a scaleStandard Deviation 0.8
FentanylSatisfaction With Anesthesia Assessed by the ISAS2.2 score on a scaleStandard Deviation 0.9
Secondary

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

Time frame: Immediately postoperatively

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
KetamineNumber of Participants Administered Additional Pain Medications23 Participants
FentanylNumber of Participants Administered Additional Pain Medications30 Participants
Secondary

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.

Time frame: 24 hours postoperatively and 7 days postoperatively

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.

ArmMeasureGroupValue (MEAN)Dispersion
KetaminePostoperative Pain Assessed by the VASPain post-op day 124.5 score on a scaleStandard Deviation 24.2
KetaminePostoperative Pain Assessed by the VASPain post-op day 718.2 score on a scaleStandard Deviation 21
FentanylPostoperative Pain Assessed by the VASPain post-op day 122 score on a scaleStandard Deviation 23
FentanylPostoperative Pain Assessed by the VASPain post-op day 719.1 score on a scaleStandard Deviation 27.1
Secondary

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.

Time frame: Immediately postoperatively

ArmMeasureValue (MEAN)Dispersion
KetamineProvider Satisfaction With Anesthesia Assessed by the VAS90 score on a scaleStandard Deviation 15.8
FentanylProvider Satisfaction With Anesthesia Assessed by the VAS86.8 score on a scaleStandard Deviation 21.3

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026