NCT01566253

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Caesarian Section

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-03-29
• Last updated: 2013-04-04

Locations

1 site across 1 country: France