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The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of brain vessels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isoton sodium chloride | Placebo Comparator |
| |
| Prostaglandin F2alpha | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostaglandin F2alpha | Drug | intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Headache score on a 10-point verbal rating scale (VRS) 0 indicated no headache; 1 indicated a different sensation, pounding or throbbing, but not necessarily painful; 5 indicated moderate headache and 10 indicated worst imaginable headache | incidence of headache | 24 h. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz) | changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0. | in-hospital 2 h. |
| diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Troels Wienecke, MD,PhD | Danish Headache Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center | Glostrup Municipality | 2600 | Denmark |
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| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015237 | Dinoprost |
| ID | Term |
|---|---|
| D011460 | Prostaglandins F |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Isoton sodium chloride | Drug | intravenous injection |
|
|
changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0. |
| in-hospital 2 h. |
| mean arterial blood pressure (MAP), heart rate (HR), end-tidal partial pressure of pCO2 (PetCO2), transcutaneous arterial oxygen saturation (SAT) measured by ProPac Encore® | changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0. | in-hospital 2 h. |
| electrocardiography (ECG) | changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0. | in-hospital 2 h. |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |