Abortion, InducedNCT00188071
Postoperative Pain After Medical Abortion Under Local Anesthesia : Comparison of Several Analgesic Regimen
A study testing paracetamol, ketoprofen and ketoprofen + paracetamol in people with Abortion, Induced, run by University Hospital, Angers at 1 site in France.
Trial summary
To compare postoperative analgesia by paracetamol 1gr or ketoprofen 100 mg or the combination of these two analgesics each treatment beeing allocated by randomization Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion, Induced
- What is being tested?
- paracetamol, ketoprofen and ketoprofen + paracetamol
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2002to Aug 2003
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant women
- medical abortion performed in day case surgery under local anesthesia
- informed written consent
Who cannot join
- under 18 year old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain After Medical Abortion Under Local Anesthesia : a Prospective and Randomized Trial Comparing Several Analgesic Regimen
- To compare postoperative analgesia by paracetamol 1gr or ketoprofen 100 mg or the combination of these two analgesics
- each treatment beeing allocated by randomization
Read the detailed description
- 240 pregnant women who undewent a medical abortion by aspiration, under local anesthesia, (day case surgery) were enrolled after informed consent and signed approval
- according to randomization, they received one hour before medical abortion procedure performed under local anesthesia of the cervix, one of these three diffrente analgesics :
- paracetamol 1 gr
- ketoprofen 100 mg
- the association of both Postprocedure pain was recorded, by nurse, using a visual analog scale (VAS), 7 times before and after the procedure, until the discharge of the patient.
- if VAS was above 40 on two consecutive measurements a morphine injection was given.
- the number and total amount of morphine was recorded.
- satisfaction was recorded within the 3 postoperative day by a telephone inquiry.
- Conditions
- Abortion, Induced
- Being tested
- paracetamol, ketoprofen, ketoprofen + paracetamol
- Keywords
- medical abortion, analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
ketoprofenDrug
ketoprofen + paracetamolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain rating
Secondary outcomes (2)
morphine consumption
patient satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2002
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, InducedStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- Jean Claude Granry, MD, Study chair, University Hospital, AngersEmmanuel Mucci, MD, Principal investigator, University Hospital, AngersChristine Monrigal, MD, Study director, Dept of Anesthesia, CHU, Angers - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188071
- Sponsor's protocol ID
- CP 02-02
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 1 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Medical Abortion Under Local Anesthesia : a Prospective and Randomized Trial Comparing Several Analgesic Regimen
- ClinicalTrials.gov ID
- NCT00188071
- Acronym / sponsor ID
- CP 02-02
- Conditions
- Abortion, Induced
- Keywords
- medical abortion, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Sep 2002
- Study completion
- Aug 2003
- First posted
- 16 Sep 2005 (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.
- To compare postoperative analgesia by paracetamol 1gr or ketoprofen 100 mg or the combination of these two analgesics
- each treatment beeing allocated by randomization
Detailed description
- 240 pregnant women who undewent a medical abortion by aspiration, under local anesthesia, (day case surgery) were enrolled after informed consent and signed approval
- according to randomization, they received one hour before medical abortion procedure performed under local anesthesia of the cervix, one of these three diffrente analgesics :
- paracetamol 1 gr
- ketoprofen 100 mg
- the association of both Postprocedure pain was recorded, by nurse, using a visual analog scale (VAS), 7 times before and after the procedure, until the discharge of the patient.
- if VAS was above 40 on two consecutive measurements a morphine injection was given.
- the number and total amount of morphine was recorded.
- satisfaction was recorded within the 3 postoperative day by a telephone inquiry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pregnant women
- medical abortion performed in day case surgery under local anesthesia
- informed written consent
Key exclusion criteria (1 listed)
- under 18 year old
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 |
|---|---|---|
| paracetamol | Drug | – |
| ketoprofen | Drug | – |
| ketoprofen + paracetamol | Drug | – |
Primary outcome
postoperative pain rating
2 secondary outcomes
morphine consumption
patient satisfaction
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 1 Nov 2017.
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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.
Jean Claude Granry, MD study chair
University Hospital, Angers
Emmanuel Mucci, MD principal investigator
University Hospital, Angers
Christine Monrigal, MD study director
Dept of Anesthesia, CHU, Angers - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paracetamol, ketoprofen and ketoprofen + paracetamol in people with Abortion, Induced, run by University Hospital, Angers 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 3 inclusion and 1 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 1 Nov 2017. 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.
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?
postoperative pain rating. 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 1 Nov 2017.