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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 29, 2014