Oral Self Medication Versus IV Administration of Pain Killers After Caesarian Delivery
Comparison of a Patient Controlled Oral Administration (PCOA) of Analgesic Protocol With an IV Administration After Planned Caesarian Section : Monocentric, Randomised and Controlled Study
2 other identifiers
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedApril 4, 2013
April 1, 2013
9 months
March 27, 2012
April 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Onset of the first request of rescue analgesic drug
maximum 48 hours following the caesarian
Study Arms (2)
PCOA
EXPERIMENTALThe PCOA arm receiving oral self administered multimodal analgesic protocol (paracetamol, ketoprofen, morphine) by oral use.
Standard/ IV
ACTIVE COMPARATORThe standard/IV arm will be received the analgesic treatment by intravenous use, administered by nursing staff.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- planned caesarian section
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
university Hospital, Arnaud de Villeneuve, Gynecology department
Montpellier, 34295, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Estelle Morau, Doctor
University Hosptial of Montpellier
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2012
First Posted
March 29, 2012
Study Start
March 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
April 4, 2013
Record last verified: 2013-04