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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: Completed Phase 4 study, sponsored by Columbia University.
NCT01846221 is a Phase 4 study that has completed, run by Columbia University. The registered enrollment target is 101 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pain Visual Analogue Scale (VAS) was evaluated every 5 min for 15 min. 'Success' is defined as at least a 4-point reduction in VAS at 15 min. (0=no pain, 10= worst pain)
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 |
What the finished NCT01846221 record still lists
NCT01846221 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Fentanyl is the first listed.
NCT01846221 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01846221's enrollment target sits among peer trials
101 766th of 2000 higher than 1,231 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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