Abortion in First Trimester, Opioid Use, Pain, Procedural
Conditions
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
IV ketamine
IV fentanyl
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Anesthesia Assessed by the ISAS | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Provider Satisfaction With Anesthesia Assessed by the VAS | 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. |
| Number of Participants Administered Additional Pain Medications | Immediately postoperatively | After the procedure, research personnel will ask anesthetist what medications, if any, they gave outside of the study protocol |
| Postoperative Pain Assessed by the VAS | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 105 |
Baseline characteristics
| Characteristic | Fentanyl | Ketamine | Total |
|---|---|---|---|
| Age, Continuous | 27.5 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 Participants | 10 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 42 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gestational age | 6.4 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 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 7 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 13 Participants | 24 Participants |
| Race (NIH/OMB) White | 17 Participants | 24 Participants | 41 Participants |
| Sex: Female, Male Female | 53 Participants | 52 Participants | 105 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 53 |
| other Total, other adverse events | 0 / 52 | 0 / 53 |
| serious Total, serious adverse events | 0 / 52 | 0 / 53 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine | Satisfaction With Anesthesia Assessed by the ISAS | 2.4 score on a scale | Standard Deviation 0.8 |
| Fentanyl | Satisfaction With Anesthesia Assessed by the ISAS | 2.2 score on a scale | Standard Deviation 0.9 |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine | Number of Participants Administered Additional Pain Medications | 23 Participants |
| Fentanyl | Number of Participants Administered Additional Pain Medications | 30 Participants |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketamine | Postoperative Pain Assessed by the VAS | Pain post-op day 1 | 24.5 score on a scale | Standard Deviation 24.2 |
| Ketamine | Postoperative Pain Assessed by the VAS | Pain post-op day 7 | 18.2 score on a scale | Standard Deviation 21 |
| Fentanyl | Postoperative Pain Assessed by the VAS | Pain post-op day 1 | 22 score on a scale | Standard Deviation 23 |
| Fentanyl | Postoperative Pain Assessed by the VAS | Pain post-op day 7 | 19.1 score on a scale | Standard Deviation 27.1 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine | Provider Satisfaction With Anesthesia Assessed by the VAS | 90 score on a scale | Standard Deviation 15.8 |
| Fentanyl | Provider Satisfaction With Anesthesia Assessed by the VAS | 86.8 score on a scale | Standard Deviation 21.3 |