Oral Self Medication Versus IV Administration of Pain Killers After Caesarian Delivery

Study Overview
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Brief Summary
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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.

Detailed Description
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Two Arms: PCOA group receiving oral self administered multimodal analgesic protocol and IV group receiving same multimodal analgesic protocol administered by nursing staff.

Official Title
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Comparison of a Patient Controlled Oral Administration (PCOA) of Analgesic Protocol With an IV Administration After Planned Caesarian Section : Monocentric, Randomised and Controlled Study

Conditions
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Caesarian Section

Intervention / Treatment
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* Drug: Acetaminophen, ketoprofen, morphine
* Drug: Acetaminophen, ketoprofen,morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: planned caesarian section Exclusion Criteria: delivery bleeding which requires general anaesthetic and other surgical treatment contraindication of the targetted anaesthetic because of hemostatis dysfunctionments Signed consent form under 18 years old, toxicomania do not french speacking allergia or contraindication to IMPs suffer from chronicle disease do not affiliate to a health protection do not want to cooperate with the medical staff

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCOA<br>The PCOA arm receiving oral self administered multimodal analgesic protocol (paracetamol, ketoprofen, morphine) by oral use. | Drug: Acetaminophen, ketoprofen, morphine<br>* 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<br>* Other names: Actiskenan 10 mg, MA 561958-9;|
| Active Comparator: Standard/ IV<br>The standard/IV arm will be received the analgesic treatment by intravenous use, administered by nursing staff. | Drug: Acetaminophen, ketoprofen,morphine<br>* 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.<br>* Other names: Morphine IV : MA #566945-2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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planned caesarian section, analgesic, PCOA