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

Caesarian Section Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566253
• Other study ID #: 8832
• Secondary ID: 2011-004919-23
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2012
• Last updated: April 3, 2013
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Caesarian Section

Intervention

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
• 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.

Locations

Country	Name	City	State
France	university Hospital, Arnaud de Villeneuve, Gynecology department	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Club anesthésie Reanimation Obstetricale

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No