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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | IV ketamine |
| |
| Fentanyl |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At discharge or 30 minutes after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Chin, MD | Fellow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedar River Clinic | Renton | Washington | 98057 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35926204 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We recruited and randomized 110 participants. After randomization, 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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Ketamine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | At discharge or 30 minutes after the procedure |
|
1 week after procedure
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Complex Family Planning Division | University of Washington | 206.221.9074 | uwfp@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 25, 2021 | Feb 25, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 2, 2022 | Feb 3, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
IV fentanyl |
|
| 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 |
| 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. | 24 hours postoperatively and 7 days postoperatively |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Gestational age | Mean | Standard Deviation | weeks |
|
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 |
| OG001 | 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 |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately postoperatively |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Immediately postoperatively |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 24 hours postoperatively and 7 days postoperatively |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | 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 | 0 | 53 | 0 | 53 | 0 | 53 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |