CurettageNCT01947205
Pain and Suction Curettage
A study testing paracetamol, dexketoprofen trometamol and suction curettage in people with Curettage and Analgesia, run by Gökhan Açmaz at 1 site in Turkey (Türkiye).
Trial summary
Aim of the study was to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray and paracervical block with ultracaine on curettage procedure. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Curettage, Analgesia, Paracervical Block
- What is being tested?
- paracetamol, dexketoprofen trometamol and suction curettage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2012to Aug 2013
- 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- pregnant participants between 35-48 days of gestation (5 to 7 weeks of gestation) pregnant participants with a single viable intrauterine pregnancy requesting termination of pregnancy.
Who cannot join
- incomplete abortions, diabetes mellitus, tendency to bleed such as thrombocytopenia, factor deficiency and functional disorders of platelets… etc, pelvic infection, known cervical stenosis, significantly impaired respiratory or cardiac conduction functions, active liver disease, renal disease, previous adverse reaction to any of the drugs used in the study, and patients who are unable to understand how to score a 10-cm visual analog scale (VAS) pain score. Moreover, patients who described chronic pelvic pain prior to the study or patients who rated their pain level on a continuous 100-mm VAS different from 0 (no pain) just before the study were not included into study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri Education and Research Hospital of Medicine
Kayseri, 38039
About this study
Aim of the study was to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray and paracervical block with ultracaine on curettage procedure.
- Conditions
- Curettage, Analgesia, Paracervical Block, Paracetamol
- Being tested
- paracetamol, dexketoprofen trometamol, suction curettage, without drug
- Keywords
- Curettage, analgesia, paracervical block, paracetamol, lidocaine, Dexketoprofen trometamol
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
dexketoprofen trometamolDrug
suction curettageDrug
Also called two puff xylocain administration
suction curettageDrug
Also called paracervical block with ultracaine
without drugOther
| Study group | Role | What they receive |
|---|---|---|
| paracetamol | Active comparator | Duration Receives: Drug: paracetamol |
| without drug | Active comparator | Control group Receives: Other: without drug |
| dexketoprofen trometamol | Active comparator | Study group Receives: Drug: dexketoprofen trometamol |
| two puff xylocain administration on cervical surface | Active comparator | Study group Receives: Drug: suction curettage |
| paracervical block with ultracaine | Active comparator | study group Receives: Drug: suction curettage |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain reduction
Measured: nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startNov 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CurettageStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gökhan Açmaz
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Gökhan Açmaz, Kayseri Education and Research Hospital
- Investigators
- Gökhan Açmaz, MD, Principal investigator, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947205
- Sponsor's protocol ID
- Kayseri ERH
- Other IDs
- KayseriERH
- Status last verified
- Sep 2013
- First submitted
- 16 Sep 2013
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Acmaz G, Aksoy H, Ozoglu N, Aksoy U, Albayrak E. Effect of paracetamol, dexketoprofen trometamol, lidocaine spray, and paracervical block application for pain relief during suction termination of first-trimester pregnancy. Biomed Res Int. 2013;2013:869275. doi: 10.1155/2013/869275. Epub 2013 Dec 24.
PubMed 24455735
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Suction Curettage
- ClinicalTrials.gov ID
- NCT01947205
- Acronym / sponsor ID
- Kayseri ERH
- Conditions
- Curettage, Analgesia, Paracervical Block, Paracetamol
- Keywords
- Curettage, analgesia, paracervical block, paracetamol, lidocaine, Dexketoprofen trometamol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Gökhan AçmazOther government
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Sep 2013 (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.
Aim of the study was to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray and paracervical block with ultracaine on curettage procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| paracetamol | Active comparator | Drug: paracetamolDuration |
| without drug | Active comparator | Other: without drugControl group |
| dexketoprofen trometamol | Active comparator | Drug: dexketoprofen trometamolStudy group |
| two puff xylocain administration on cervical surface | Active comparator | Drug: suction curettageStudy group |
| paracervical block with ultracaine | Active comparator | Drug: suction curettagestudy group |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- pregnant participants between 35-48 days of gestation (5 to 7 weeks of gestation) pregnant participants with a single viable intrauterine pregnancy requesting termination of pregnancy.
Key exclusion criteria (1 listed)
- incomplete abortions, diabetes mellitus, tendency to bleed such as thrombocytopenia, factor deficiency and functional disorders of platelets… etc, pelvic infection, known cervical stenosis, significantly impaired respiratory or cardiac conduction functions, active liver disease, renal disease, previous adverse reaction to any of the drugs used in the study, and patients who are unable to understand how to score a 10-cm visual analog scale (VAS) pain score. Moreover, patients who described chronic pelvic pain prior to the study or patients who rated their pain level on a continuous 100-mm VAS different from 0 (no pain) just before the study were not included into study.
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 | paracetamol |
| dexketoprofen trometamol | Drug | dexketoprofen trometamol |
| suction curettageAlso: two puff xylocain administration | Drug | two puff xylocain administration on cervical surface |
| suction curettageAlso: paracervical block with ultracaine | Drug | paracervical block with ultracaine |
| without drug | Other | without drug |
Primary outcome
pain reduction
Time frame: nine months
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 20 Sep 2013.
- Derived from this study: PubMed 24455735Acmaz G, Aksoy H, Ozoglu N, Aksoy U, Albayrak E. Effect of paracetamol, dexketoprofen trometamol, lidocaine spray, and paracervical block application for pain relief during suction termination of first-trimester pregnancy. Biomed Res Int. 2013;2013:869275. doi: 10.1155/2013/869275. Epub 2013 Dec 24.
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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.
Gökhan Açmaz, MD principal investigator
Kayseri Education and Research Hospital
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, dexketoprofen trometamol and suction curettage in people with Curettage and Analgesia, run by Gökhan Açmaz at 1 site in Turkey (Türkiye).
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 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 20 Sep 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 Turkey (Türkiye). 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?
pain reduction (time frame: nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01947205, which also lists 1 linked publication.
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 20 Sep 2013.