Pain and CurettageNCT01993589
Effect of Paracetamol, Dexketoprofen Trometamol, Lidocaine Spray, Pethidine and Diclofenac Sodium Application for Pain Relief During Fractional Curettage
A study testing comparison of pain relievers during curattage and comparison of pain relievers in people with Pain and Curettage, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients frequently experience pain from moderate to severe during gynecologic procedures. This study is a prospective, randomized, placebo-controlled trial and aimed to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray, pethidine and diclofenac… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain and Curettage
- What is being tested?
- comparison of pain relievers during curattage and comparison of pain relievers
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2012to Nov 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- multiparous participants
- abnormal uterine bleeding
- postmenopausal bleeding
- myoma uteri causing menometrorrhagia
- cervical polyp
- tamoxifen treatment for breast cancer
- adnexial mass
Who cannot join
- abortions
- pregnancy
- primiparity
- diabetes mellitus
- tendency to bleed such as thrombocytopenia
- factor deficiency
- functional disorders of platelets
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri Education and Research Hospital of Medicine
Kayseri, 38210
About this study
Patients frequently experience pain from moderate to severe during gynecologic procedures. This study is a prospective, randomized, placebo-controlled trial and aimed to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray, pethidine and diclofenac sodium on fractional curettage procedure.
Read the detailed description
A total of 144 mutiparous subjects randomly allocated one of six groups. The first group (control group) consisted of 22 participants and they did not receive any treatment. The second group consisted of 26 participants receiving oral 25 mg dexketoprofen trometamol. The third group consisted of 23 participants receiving 2 puff lidocaine sprays on cervical mucosa. The forth group consisted of 25 participants receiving 100 mg pethidine. The fifth group consisted of 23 participants receiving 1000 mg intravenous paracetamol and the sixth group consisted of 25 participants receiving diclofenac sodium.
- Conditions
- Pain and Curettage
- Being tested
- comparison of pain relievers during curattage, comparison of pain relievers
- Keywords
- Curettage; analgesia; paracetamol; lidocaine; Dexketoprofen trometamol; pethidine; diclofenac.
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of pain relievers during curattageDrug
comparison of pain relieversDrug
comparison of pain relievers during curattageDrug
comparison of pain relievers during curattageDrug
comparison of pain relievers during curattageDrug
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group |
| Pain reliever | Active comparator | 1000 mg paracetamol (Parol 1 g Atabay ilaç Turkey) Receives: Drug: comparison of pain relievers during curattage |
| Dexketoprofen trometamol | Active comparator | 25 mg oral Dexofen Atabay ilaç Turkey Receives: Drug: comparison of pain relievers |
| Lidocaine spray | Active comparator | 2 puff on cervical mucosa (Xylocain Pump 100 Mg 50 Ml Sprey Astra Zeneca) Receives: Drug: comparison of pain relievers during curattage |
| pethidine | Active comparator | Aldolan 100 mg Liba Laboratuarı İstanbul Turkey Receives: Drug: comparison of pain relievers during curattage |
| diclofenac sodium | Active comparator | Dicloron amp 75 mg Deva İlaç Levent İstanbul/Turkey Receives: Drug: comparison of pain relievers during curattage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2013
- Study completionNov 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 Pain and 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gökhan Açmaz, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993589
- Sponsor's protocol ID
- {kayseriERH}
- Status last verified
- Nov 2013
- First submitted
- 9 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Acmaz G, Bayraktar E, Aksoy H, Baser M, Yilmaz MO, Muderris II. Effect of paracetamol, dexketoprofen trometamol, lidocaine spray, pethidine & diclofenac sodium application for pain relief during fractional curettage: A randomized controlled trial. Indian J Med Res. 2015 Oct;142(4):399-404. doi: 10.4103/0971-5916.169197.
PubMed 26609031
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Paracetamol, Dexketoprofen Trometamol, Lidocaine Spray, Pethidine and Diclofenac Sodium Application for Pain Relief During Fractional Curettage
- ClinicalTrials.gov ID
- NCT01993589
- Acronym / sponsor ID
- {kayseriERH}
- Conditions
- Pain and Curettage
- Keywords
- Curettage; analgesia; paracetamol; lidocaine; Dexketoprofen trometamol; pethidine; diclofenac.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Nov 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.
Patients frequently experience pain from moderate to severe during gynecologic procedures. This study is a prospective, randomized, placebo-controlled trial and aimed to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray, pethidine and diclofenac sodium on fractional curettage procedure.
Detailed description
A total of 144 mutiparous subjects randomly allocated one of six groups. The first group (control group) consisted of 22 participants and they did not receive any treatment. The second group consisted of 26 participants receiving oral 25 mg dexketoprofen trometamol. The third group consisted of 23 participants receiving 2 puff lidocaine sprays on cervical mucosa. The forth group consisted of 25 participants receiving 100 mg pethidine. The fifth group consisted of 23 participants receiving 1000 mg intravenous paracetamol and the sixth group consisted of 25 participants receiving diclofenac sodium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group |
| Pain reliever | Active comparator | Drug: comparison of pain relievers during curattage1000 mg paracetamol (Parol 1 g Atabay ilaç Turkey) |
| Dexketoprofen trometamol | Active comparator | Drug: comparison of pain relievers25 mg oral Dexofen Atabay ilaç Turkey |
| Lidocaine spray | Active comparator | Drug: comparison of pain relievers during curattage2 puff on cervical mucosa (Xylocain Pump 100 Mg 50 Ml Sprey Astra Zeneca) |
| pethidine | Active comparator | Drug: comparison of pain relievers during curattageAldolan 100 mg Liba Laboratuarı İstanbul Turkey |
| diclofenac sodium | Active comparator | Drug: comparison of pain relievers during curattageDicloron amp 75 mg Deva İlaç Levent İstanbul/Turkey |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- multiparous participants
- abnormal uterine bleeding
- postmenopausal bleeding
- myoma uteri causing menometrorrhagia
- cervical polyp
Key exclusion criteria (7 listed)
- abortions
- pregnancy
- primiparity
- diabetes mellitus
- tendency to bleed such as thrombocytopenia
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 |
|---|---|---|
| comparison of pain relievers during curattage | Drug | Pain reliever |
| comparison of pain relievers | Drug | Dexketoprofen trometamol |
| comparison of pain relievers during curattage | Drug | Lidocaine spray |
| comparison of pain relievers during curattage | Drug | pethidine |
| comparison of pain relievers during curattage | Drug | diclofenac sodium |
Primary outcome
Pain
Time frame: 1 year
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 25 Nov 2013.
- Derived from this study: PubMed 26609031Acmaz G, Bayraktar E, Aksoy H, Baser M, Yilmaz MO, Muderris II. Effect of paracetamol, dexketoprofen trometamol, lidocaine spray, pethidine & diclofenac sodium application for pain relief during fractional curettage: A randomized controlled trial. Indian J Med Res. 2015 Oct;142(4):399-404. doi: 10.4103/0971-5916.169197.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comparison of pain relievers during curattage and comparison of pain relievers in people with Pain and Curettage, run by Kayseri Education and Research Hospital 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 7 inclusion and 7 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 25 Nov 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 (time frame: 1 year). 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 NCT01993589, 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 25 Nov 2013.