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Completed

NCT Number: NCT01566253

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

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.

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Key information

Conditions

Caesarian Section

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

university Hospital, Arnaud de Villeneuve, Gynecology department

Montpellier, 34295, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen, ketoprofen, morphine

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

Other names: dolipraneoro 500mg, MA 352 120-2, bi profenid LP 100 mg, MA 399804-5, Actiskenan 10 mg, MA 561958-9

Acetaminophen, ketoprofen,morphine

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.

Other names: Paracetamol 1g/100 ml IV : MA #571860-1, Profenid IV : MA #557466-8, Morphine IV : MA #566945-2

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Club anesthésie Reanimation Obstetricale

Registry information

Official study title

Comparison of a Patient Controlled Oral Administration (PCOA) of Analgesic Protocol With an IV Administration After Planned Caesarian Section : Monocentric, Randomised and Controlled Study

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2012
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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