Caesarian SectionPhase 4NCT01566253
Oral Self Medication Versus IV Administration of Pain Killers After Caesarian Delivery
A Phase 4 study testing Acetaminophen, ketoprofen, morphine and Acetaminophen, ketoprofen,morphine in people with Caesarian Section, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Caesarian Section
- What is being tested?
- Acetaminophen, ketoprofen, morphine and Acetaminophen, ketoprofen,morphine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- planned caesarian section
Who cannot join
- 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
Show all 9Show fewer
- suffer from chronicle disease
- do not affiliate to a health protection
- do not want to cooperate with the medical staff
Trial locations and contacts
1 site in 1 country.
France1 site
university Hospital, Arnaud de Villeneuve, Gynecology department
Montpellier, 34295
About this study
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
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.
Read the 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
- Being tested
- Acetaminophen, ketoprofen, morphine, Acetaminophen, ketoprofen,morphine
- Keywords
- planned caesarian section, analgesic, PCOA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen, ketoprofen, morphineDrug
Also called dolipraneoro 500mg, MA 352 120-2, bi profenid LP 100 mg, MA 399804-5, Actiskenan 10 mg, MA 561958-9
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,morphineDrug
Also called Paracetamol 1g/100 ml IV : MA #571860-1, Profenid IV : MA #557466-8, Morphine IV : MA #566945-2
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 group | Role | What they receive |
|---|---|---|
| PCOA | Experimental | The PCOA arm receiving oral self administered multimodal analgesic protocol (paracetamol, ketoprofen, morphine) by oral use. Receives: Drug: Acetaminophen, ketoprofen, morphine |
| Standard/ IV | Active comparator | The standard/IV arm will be received the analgesic treatment by intravenous use, administered by nursing staff. Receives: Drug: Acetaminophen, ketoprofen,morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 48 hours
Secondary outcomes (1)
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.
Measured: maximum 48 hours following the caesarian
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarian SectionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Club anesthésie Reanimation Obstetricale
- Responsible party
- Sponsor
- Investigators
- Estelle Morau, Doctor, Principal investigator, University Hosptial of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566253
- Sponsor's protocol ID
- 8832
- Other IDs
- 2011-004919-23
- Status last verified
- Apr 2013
- First submitted
- 27 Mar 2012
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01566253
- Acronym / sponsor ID
- 8832
- Conditions
- Caesarian Section
- Keywords
- planned caesarian section, analgesic, PCOA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Club anesthésie Reanimation Obstetricale
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOA | Experimental | Drug: Acetaminophen, ketoprofen, morphineThe PCOA arm receiving oral self administered multimodal analgesic protocol (paracetamol, ketoprofen, morphine) by oral use. |
| Standard/ IV | Active comparator | Drug: Acetaminophen, ketoprofen,morphineThe standard/IV arm will be received the analgesic treatment by intravenous use, administered by nursing staff. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- planned caesarian section
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen, ketoprofen, morphineAlso: dolipraneoro 500mg, MA 352 120-2, bi profenid LP 100 mg, MA 399804-5, Actiskenan 10 mg, MA 561958-9Acetaminophen 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 | PCOA |
| Acetaminophen, ketoprofen,morphineAlso: Paracetamol 1g/100 ml IV : MA #571860-1, Profenid IV : MA #557466-8, Morphine IV : MA #566945-2Acetaminophen 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. | Drug | Standard/ IV |
Primary outcome
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.
1 secondary outcome
Onset of the first request of rescue analgesic drug
Time frame: maximum 48 hours following the caesarian
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
Related trials for Caesarian Section
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Estelle Morau, Doctor principal investigator
University Hosptial of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen, ketoprofen, morphine and Acetaminophen, ketoprofen,morphine in people with Caesarian Section, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median pain score during the first 48 hours (Verbal rating PAin Scale) (time frame: After 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.