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NCT01846221 · ClinicalTrials.gov registry record · Phase 4
Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain
A Phase 4 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 4
- Development phase
- 101
- Enrollment target
NCT01846221 is a Phase 4 study that has completed, run by Columbia University. The registered enrollment target is 101 participants.
The verdict
NCT01846221, a Phase 4 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 101 participants
- Enrollment target
Study Summary
Epidural analgesia has proven to be an effective method for severe pain relief associated with labor and delivery. During labor, a low dose continuous infusion of local anesthetic and narcotic will be administered through an epidural catheter. As labor progresses and the baby's head makes it way through the pelvis, breakthrough pain may emerge and often needs further treatment. The investigators provide pain relief by administering analgesics through the epidural catheter. The patients will be randomly assigned to receive one of two medication mixtures believed to be successful in treating this type of pain associated with advanced labor. After this initial treatment, if pain relief is not attained, the patient may receive the other medication as well. The medications used in this study have been used at this institution for some time and have been found to be safe for mother and baby. The opioid (fentanyl) dose is small and only a small fraction will be transmitted to the baby. The other medication (clonidine) better known as a blood pressure medication has also been used for pain relief. Studies and clinical experience have shown that clonidine when given epidurally in the doses used in this study has minimal, if any effect, on the blood pressure of the mother or of the baby. The investigators will record medical and obstetric history and labor progress relevant to the patient. The patient will be asked questions regarding labor pain and side effects before and after the analgesic is administered. The primary objective is to determine which treatment regimen is more successful in abolishing breakthrough pain in advanced labor.
Interventions
- DRUG Fentanyl
- DRUG Clonidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2014-07-15 |
| Est. Completion | 2017-01-20 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01846221
The ClinicalTrials.gov registry entry for NCT01846221 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fentanyl is the first listed.
NCT01846221 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01846221 about?
NCT01846221 is a clinical study titled "Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain". Epidural analgesia has proven to be an effective method for severe pain relief associated with labor and delivery. During labor, a low dose continuous infusion of local anesthetic and narcotic will be administered through an epidural catheter. As labor progresses and the baby's head makes it way thr...
What is the current status of trial NCT01846221?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 101 participants. The study started on 2014-07-15. Estimated completion is 2017-01-20.
What interventions are being tested in trial NCT01846221?
The interventions under investigation include: Fentanyl (DRUG), Clonidine (DRUG).
Who is sponsoring clinical trial NCT01846221?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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