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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2012

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.

Interventions

  • 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
  • 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.

Arms, Groups and Cohorts

  • Experimental: PCOA
    • The PCOA arm receiving oral self administered multimodal analgesic protocol (paracetamol, ketoprofen, morphine) by oral use.
  • Active Comparator: Standard/ IV
    • The standard/IV arm will be received the analgesic treatment by intravenous use, administered by nursing staff.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Montpellier
  • Collaborator
    • Club anesthésie Reanimation Obstetricale
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Estelle Morau, Doctor, Principal Investigator, University Hosptial of Montpellier

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