Oral Self Medication Versus IV Administration of Pain Killers After Caesarian Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01566253
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : April 4, 2013
Club anesthésie Reanimation Obstetricale
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment Phase
Caesarian Section Drug: Acetaminophen, ketoprofen, morphine Drug: Acetaminophen, ketoprofen,morphine Phase 4

Detailed Description:
Two Arms: PCOA group receiving oral self administered multimodal analgesic protocol and IV group receiving same multimodal analgesic protocol administered by nursing staff.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PCOA
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
Other Names:
  • dolipraneoro 500mg, MA 352 120-2
  • bi profenid LP 100 mg, MA 399804-5
  • Actiskenan 10 mg, MA 561958-9
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.
Other Names:
  • Paracetamol 1g/100 ml IV : MA #571860-1
  • Profenid IV : MA #557466-8
  • Morphine IV : MA #566945-2

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • planned caesarian section

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01566253

university Hospital, Arnaud de Villeneuve, Gynecology department
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Club anesthésie Reanimation Obstetricale
Principal Investigator: Estelle Morau, Doctor University Hosptial of Montpellier

Responsible Party: University Hospital, Montpellier Identifier: NCT01566253     History of Changes
Other Study ID Numbers: 8832
2011-004919-23 ( EudraCT Number )
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by University Hospital, Montpellier:
planned caesarian section, analgesic, PCOA

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action