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| Name | Class |
|---|---|
| Admescope Ltd | INDUSTRY |
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Physiological changes during pregnancy are known to affect the pharmacokinetics of many drugs. Intranasal fentanyl is an interesting option for obstetric analgesia, but its use in pregnant patients has not been established. The investigators studied pharmacokinetics of intranasal fentanyl in labouring women and to subsequently evaluate the maternal and fetal safety after administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal fentanyl 50 microg/dose | Experimental | patient was given intranasal fentanyl 50 microg/dose up to 250 microg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intranasal fentanyl 50 microg dose up to 250 microg | Drug | When contraction pain was ≥ 5/10 (numerical rating scale 0= no pain, 10= worst pain), the parturient was given a intranasal fentanyl 50 µg dose. After 15 minutes, if contraction pain was still ≥ 5/10, a second 50 µg intranasal dose was administered. Fentanyl was administered every 15 minute until contraction pain decreased to less than 5/10 or until the maximum fentanyl dose of 250 µg was administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Fentanyl maximum concentration | From the first intranasal fentanyl dose to birth of the newborn up to 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
Not agreed to participate
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| Name | Affiliation | Role |
|---|---|---|
| Merja Kokki, PhD | Kuopio University Hospital, Kuopio, Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio University Hospital | Kuopio | Northern Savonia | 70029 | Finland |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Intranasal fentanyl
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