Oral Self Medication Versus IV Administration of Pain Killers After Caesarian Delivery
|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|
|Primary Completion Date :||December 2012|
|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.
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|