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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004919-23 | EudraCT Number |
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| Name | Class |
|---|---|
| Club anesthésie Reanimation Obstetricale | UNKNOWN |
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C-section deliveries are painful and need adequate analgesia. In the same time, mothers need early rehabilitation to take care of the baby.
Hypothesis: Early oral self administration of painkillers could be as effective as usual IV administration by nursing staff.
Purpose of the study: Evaluation of the efficacy of a program of self administration of painkillers postoperatively of C-section delivery.
Two Arms: PCOA group receiving oral self administered multimodal analgesic protocol and IV group receiving same multimodal analgesic protocol administered by nursing staff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCOA | Experimental | The PCOA arm receiving oral self administered multimodal analgesic protocol (paracetamol, ketoprofen, morphine) by oral use. |
|
| Standard/ IV | Active Comparator | The standard/IV arm will be received the analgesic treatment by intravenous use, administered by nursing staff. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen, ketoprofen, morphine | Drug | Acetaminophen 0.5g, maximum 4g by day, 48 hours ketoprofen 100 mg, twice a day, 48 hours Morphine 10 mg, maximum 90 mg by day, 36 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median pain score during the first 48 hours (Verbal rating PAin Scale) | The pain score will be assessed by investigators at different times : H2 (2 hours after the end of the caesarian), H6, H12, H18, H24, H30, H36 and H48. | After 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of the first request of rescue analgesic drug | If the study analgesic treatment is not enough, a rescue analgesic drug could administered by nursing staff. | maximum 48 hours following the caesarian |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Estelle Morau, Doctor | University Hosptial of Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| university Hospital, Arnaud de Villeneuve, Gynecology department | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007660 | Ketoprofen |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Acetaminophen, ketoprofen,morphine | Drug | Acetaminophen 1g/100 ml IV, maximum 4g by 24 hours, 48 hours Ketoprofen IV, maximum 0,2 gram by 24 hours, 48 hours Morphine IV,maximum 60mg by 24 hours, 36 hours. |
|
|
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |