Oral Self Medication Versus IV Administration of Pain Killers After Caesarian Delivery
NCT ID: NCT01566253
Last Updated: 2013-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2012-03-31
2012-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PCOA
The PCOA arm receiving oral self administered multimodal analgesic protocol (paracetamol, ketoprofen, morphine) by oral use.
Acetaminophen, ketoprofen, morphine
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
Standard/ IV
The standard/IV arm will be received the analgesic treatment by intravenous use, administered by nursing staff.
Acetaminophen, ketoprofen,morphine
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.
Interventions
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Acetaminophen, ketoprofen, morphine
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
Acetaminophen, ketoprofen,morphine
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
64 Years
FEMALE
No
Sponsors
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Club anesthésie Reanimation Obstetricale
UNKNOWN
University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Estelle Morau, Doctor
Role: PRINCIPAL_INVESTIGATOR
University Hosptial of Montpellier
Locations
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university Hospital, Arnaud de Villeneuve, Gynecology department
Montpellier, , France
Countries
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Other Identifiers
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2011-004919-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8832
Identifier Type: -
Identifier Source: org_study_id
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