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Labor pain is a major factor in making the placement of an epidural catheter difficult. The epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve this goal as fast and safely as possible it would be helpful to have a parturient who can tolerate and co-operate with the placement of the epidural catheter.
Briefly stopping contractions, the cause of labor pain, could be the key to achieve this goal.
This study will evaluate the safety, efficacy and duration of the drug terbutaline for this purpose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terbutaline | Experimental | Terbutaline 0.125mg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN |
|
| Fentanyl | Active Comparator | Fentanyl 100mcg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN |
|
| Placebo | Placebo Comparator | 0.9% NaCl i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terbutaline | Drug |
| ||
| Fentanyl |
| Measure | Description | Time Frame |
|---|---|---|
| reduction of pain score on a visual analog scale (VAS) of 1-10 | semi-quantitative assessment of decrease in the subject's pain score after administration of the study drug for the placement of an epidural catheter | 0-30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| movement during epidural placement | semi-quantitative assessment of the subject's movement during placement of the epidural catheter: 0-1-2-3: none - extremities - trunk a bit - trunk a lot | 0-30 minutes |
| position during epidural placement |
| Measure | Description | Time Frame |
|---|---|---|
| hemodynamic and oxygenation assessment of parturient and fetus, side effects | heart rate (HR), non-invasive blood pressure (NIBP), pulse-oximetry (SpO2), fetal heart rate (FHR), uterine contractions (CTG - cardiotocogram); feeling of being jittery, pruritus and nausea | 0-30 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kai Schoenhage, MD | Contact | (520) 626-7221 | kschoenhage@anesth.arizona.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kai Schoenhage, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Medical Center | Recruiting | Tucson | Arizona | 85712 | United States |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013726 | Terbutaline |
| D005283 | Fentanyl |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| 0.9% NaCl | Drug |
|
|
semi-quantitative assessment of the subject's position during the epidural catheter placement: 0-1-2: excellent - moderate - poor
| 0-30 minutes |
| University of Arizona Medical Center | Recruiting | Tucson | Arizona | 85724 | United States |
|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |