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

NCT ID: NCT01566253

Last Updated: 2013-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Two Arms: PCOA group receiving oral self administered multimodal analgesic protocol and IV group receiving same multimodal analgesic protocol administered by nursing staff.

Conditions

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Caesarian Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PCOA

The PCOA arm receiving oral self administered multimodal analgesic protocol (paracetamol, ketoprofen, morphine) by oral use.

Group Type EXPERIMENTAL

Acetaminophen, ketoprofen, morphine

Intervention Type DRUG

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

Standard/ IV

The standard/IV arm will be received the analgesic treatment by intravenous use, administered by nursing staff.

Group Type ACTIVE_COMPARATOR

Acetaminophen, ketoprofen,morphine

Intervention Type DRUG

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.

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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dolipraneoro 500mg, MA 352 120-2 bi profenid LP 100 mg, MA 399804-5 Actiskenan 10 mg, MA 561958-9 Paracetamol 1g/100 ml IV : MA #571860-1 Profenid IV : MA #557466-8 Morphine IV : MA #566945-2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Club anesthésie Reanimation Obstetricale

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Estelle Morau, Doctor

Role: PRINCIPAL_INVESTIGATOR

University Hosptial of Montpellier

Locations

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university Hospital, Arnaud de Villeneuve, Gynecology department

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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2011-004919-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

8832

Identifier Type: -

Identifier Source: org_study_id

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