A Phase 4 interventional study of Acetaminophen, ketoprofen, morphine and Acetaminophen, ketoprofen,morphine in Caesarian Section, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to female participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2013-04-04.
Sponsored by University Hospital, Montpellier · Phase 4, Interventional, and Treatment
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.
Two Arms: PCOA group receiving oral self administered multimodal analgesic protocol and IV group receiving same multimodal analgesic protocol administered by nursing staff.
University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The PCOA arm receiving oral self administered multimodal analgesic protocol (paracetamol, ketoprofen, morphine) by oral use.
Drug: Acetaminophen, ketoprofen, morphine
The standard/IV arm will be received the analgesic treatment by intravenous use, administered by nursing staff.
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
Also known as: dolipraneoro 500mg, MA 352 120-2, bi profenid LP 100 mg, MA 399804-5, Actiskenan 10 mg, MA 561958-9
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.
Also known as: Paracetamol 1g/100 ml IV : MA #571860-1, Profenid IV : MA #557466-8, Morphine IV : MA #566945-2
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.
Time frame: After 48 hours
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.
Time frame: maximum 48 hours following the caesarian
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier