Oral Self Medication Versus IV Administration of Pain Killers After Caesarian Delivery
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|ClinicalTrials.gov Identifier: NCT01566253|
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : April 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Caesarian Section||Drug: Acetaminophen, ketoprofen, morphine Drug: Acetaminophen, ketoprofen,morphine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of a Patient Controlled Oral Administration (PCOA) of Analgesic Protocol With an IV Administration After Planned Caesarian Section : Monocentric, Randomised and Controlled Study|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
The PCOA arm receiving oral self administered multimodal analgesic protocol (paracetamol, ketoprofen, morphine) by oral use.
Drug: 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
Active Comparator: Standard/ IV
The standard/IV arm will be received the analgesic treatment by intravenous use, administered by nursing staff.
Drug: 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.
- Median pain score during the first 48 hours (Verbal rating PAin Scale) [ Time Frame: After 48 hours ]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.
- Onset of the first request of rescue analgesic drug [ Time Frame: maximum 48 hours following the caesarian ]If the study analgesic treatment is not enough, a rescue analgesic drug could administered by nursing staff.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566253
|university Hospital, Arnaud de Villeneuve, Gynecology department|
|Montpellier, France, 34295|
|Principal Investigator:||Estelle Morau, Doctor||University Hosptial of Montpellier|