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NCT04871425 · ClinicalTrials.gov registry record · Phase 4
Ketamine Versus Fentanyl for Surgical Abortions
A Phase 4 study of Opioid Use and Pain, Procedural, sponsored by University of Washington.
- Completed
- Registry status
- Phase 4
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT04871425: Completed Phase 4 study of Opioid Use and Pain, Procedural, sponsored by University of Washington.
NCT04871425 is a Phase 4 study of Opioid Use and Pain, Procedural that has completed, run by University of Washington. The registered enrollment target is 110 participants, below the 148,259-participant average among 105 other Opioid Use trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04871425, a Phase 4 study of Opioid Use and Pain, Procedural, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Ketamine
- DRUG Fentanyl
Study Locations (1)
Washington
- Cedar River Clinic - Renton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2021-04-27 |
| Est. Completion | 2021-10-14 |
| Phase | Phase 4 |
What the finished NCT04871425 record still lists
NCT04871425 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 148,259-participant average among 105 other Opioid Use trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Opioid Use appearing as the primary indexed condition, and to 2 interventions - of which Ketamine is the first listed.
NCT04871425 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT04871425 about?
NCT04871425 is a clinical study titled "Ketamine Versus Fentanyl for Surgical Abortions". 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...
What is the current status of trial NCT04871425?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2021-04-27. Estimated completion is 2021-10-14.
What conditions does trial NCT04871425 study?
This clinical trial studies the following conditions: Opioid Use, Pain, Procedural, Abortion in First Trimester.
What interventions are being tested in trial NCT04871425?
The interventions under investigation include: Ketamine (DRUG), Fentanyl (DRUG).
Who is sponsoring clinical trial NCT04871425?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04871425 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04871425's enrollment target sits among peer trials
110 65th of 105 higher than 41 of 105 other Opioid Use trials
participants (enrollment target), bucketed by value
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