Phase 4
N=101
Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain
Labor Pain
Bottom Line
View on ClinicalTrials.gov: NCT01846221 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Number of Subjects With Success Rate at 15 Minutes Post-epidural Bolus Injection — 31; 38 Participants — p=0.38
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Clonidine (Drug); Fentanyl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Success Rate at 15 Minutes Post-epidural Bolus Injection |
31; 38 | 0.38 |
| SECONDARY Maternal Systolic Blood Pressure |
123; 121; 116; 118 | — |
| SECONDARY Maternal Heart Rate |
87; 84; 84; 85 | — |
| SECONDARY Neonatal Apgar Score |
8.53; 8.24; 8.94; 8.88 | — |
| SECONDARY Number of Spontaneous Vaginal Deliveries |
38; 40 | — |
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.
Eligibility Criteria
Inclusion Criteria
- women in labor at term pregnancy
- healthy
- epidural analgesia in place
- breakthrough pain in advanced labor
Exclusion Criteria
- chronic pain syndrome
- receiving systemic opioids within 4 hours
- receiving chronic antidepressants, clonidine, opioids
Data sourced from ClinicalTrials.gov (NCT01846221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.