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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01566253

Enrollment

Registered

2012-03-29

Start date

2012-03-31

Completion date

2012-12-31

Last updated

2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarian Section

Keywords

planned caesarian section, analgesic, PCOA

Brief 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.

Interventions

DRUGAcetaminophen, 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

DRUGAcetaminophen, 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Median pain score during the first 48 hours (Verbal rating PAin Scale)	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

Measure	Time frame	Description
Onset of the first request of rescue analgesic drug	maximum 48 hours following the caesarian	If the study analgesic treatment is not enough, a rescue analgesic drug could administered by nursing staff.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026