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

Phase 4

Completed

• Conditions: Caesarian Section
• Interventions: Drug: Acetaminophen, ketoprofen,morphine; Drug: Acetaminophen, ketoprofen, morphine

• Registration Number: NCT01566253
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-28
• Study First Posted: 2012-03-29
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-03
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard/ IV	Acetaminophen, ketoprofen,morphine	The standard/IV arm will be received the analgesic treatment by intravenous use, administered by nursing staff.
PCOA	Acetaminophen, ketoprofen, morphine	The PCOA arm receiving oral self administered multimodal analgesic protocol (paracetamol, ketoprofen, morphine) by oral use.

Primary Outcome Measures

Name	Time	Method
Median pain score during the first 48 hours (Verbal rating PAin Scale)	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

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

Trial Locations

Locations (1)

university Hospital, Arnaud de Villeneuve, Gynecology department; 🇫🇷 Montpellier, France