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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005510-35 | EudraCT Number |
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| Name | Class |
|---|---|
| Santelys Association | OTHER |
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The results of the study will permit to set up a standardized and validated procedure of pain management authorizing medical and paramedical staff of brachytherapy department to handle pain and in this way to improve the quality of life of the patients.
Selection criteria validation
Patient information and collection of a signed informed consent
Randomization
Completion of HADS questionnaire
Day 1 = Begin of analgesic treatment / brachytherapy
T-30= 30 minutes before the operative procedure, IV administration of the analgesic treatment (Arm A or B) by the anesthetist
T0= end of the operative procedure under general anesthesia
T4, T8, and T12 = 4, 8 and 12 hours after T0: evaluation of pain level. If pain level ≥ 4:
Day 2 to Day 30: At home or during hospital stay:
Pain assessment twice a day by the patient until absence of pain during 2 consecutive days
In any case, pain assessment must be done until absence of pain during 2 consecutive days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Paracetamol |
|
| Arm B | Experimental | Paracetamol + Ketoprofen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | Paracetamol 1 g IV then 1 g 3 times a day IV or oral (PO) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of immediate post-operative pain | Immediate post-operative pain will be assessed on a scale from 0 to 10. Experimental treatment will be considered as a success if the level of pain is < 4, 4 hours after the surgical operation. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Level of pain linked to the operative procedure during brachytherapy and at home | Assessment of the pain level at 8, 12 hours after the operative procedure, then twice a day during hospital stay or at home until the absence of pain during 2 consecutive days. This level will also be measured at days 3, 15 and 30 at hospital or during a phone interview (Days 3 and 15) and by the algologist of the investigation center on Day 30. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danièle LEFEBVRE-KUNTZ, MD | Centre Oscar Lambret | Study Director |
| Nathalie LEROUX, MD | Centre Oscar Lambret | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Lille | 59020 | France |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007660 | Ketoprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Ketoprofen | Drug | Ketoprofen* 100 mg (IV then PO) : Ketoprofen 100 mg IV 2 times a day or Ketoprofen LP 100 mg PO 2 times a day. |
|
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| Day 1 (8, 12 hours), Days 3, 15 and 30 |
| Tolerance of the analgesic treatment | assessment based on NCI-CTCAE v4.0 | 30 days |
| Assessment of anxiety | before, during and after brachytherapy by completing the HADS questionnaire | inclusion, Days 3 and 30 |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |