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

This study has been completed.
Sponsor:
Collaborator:
Club anesthésie Reanimation Obstetricale
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01566253
First received: March 27, 2012
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Caesarian Section
 Drug: Acetaminophen, ketoprofen, morphine
Drug: Acetaminophen, ketoprofen,morphine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Median pain score during the first 48 hours (Verbal rating PAin Scale) [ Time Frame: After 48 hours ] [ Designated as safety issue: No ]
    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:
  • Onset of the first request of rescue analgesic drug [ Time Frame: maximum 48 hours following the caesarian ] [ Designated as safety issue: No ]
    If the study analgesic treatment is not enough, a rescue analgesic drug could administered by nursing staff.


Enrollment: 80
Study Start Date: March 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566253

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

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01566253     History of Changes
Other Study ID Numbers: 8832, 2011-004919-23
Study First Received: March 27, 2012
Last Updated: April 3, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Acetaminophen
Ketoprofen
Analgesics
Morphine
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
 Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 22, 2013