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

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.

Study Overview

• Status: Completed
• Conditions: Caesarian Section
• Intervention / Treatment: Drug: Acetaminophen, ketoprofen, morphine; Drug: Acetaminophen, ketoprofen,morphine

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
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • university Hospital, Arnaud de Villeneuve, Gynecology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of the first request of rescue analgesic drug	If the study analgesic treatment is not enough, a rescue analgesic drug could administered by nursing staff.	maximum 48 hours following the caesarian

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Club anesthésie Reanimation Obstetricale
• Investigators: Principal Investigator: Estelle Morau, Doctor, University Hosptial of Montpellier

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 27, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Estimate): April 4, 2013
• Last Update Submitted That Met QC Criteria: April 3, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: planned caesarian section, analgesic, PCOA
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Morphine; Ketoprofen
• Other Study ID Numbers: 8832 (CTEP); 2011-004919-23 (EudraCT Number)