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

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status and phase

Completed
Phase 4

Conditions

Caesarian Section

Treatments

Drug: Acetaminophen, ketoprofen,morphine
Drug: Acetaminophen, ketoprofen, morphine

Study type

Interventional

Funder types

Other

Identifiers

NCT01566253
2011-004919-23 (EudraCT Number)
8832 (Other Identifier)

Details and patient eligibility

About

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 description

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

Enrollment

80 patients

Sex

Female

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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