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Effect of Paracetamol, Dexketoprofen Trometamol, Lidocaine Spray, Pethidine and Diclofenac Sodium Application for Pain Relief During Fractional Curettage

NCT ID: NCT01993589

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-11-30

Brief Summary

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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

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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

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Pain and Curettage

Keywords

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Curettage; analgesia; paracetamol; lidocaine; Dexketoprofen trometamol; pethidine; diclofenac.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Pain reliever

1000 mg paracetamol (Parol 1 g Atabay ilaç Turkey)

Group Type ACTIVE_COMPARATOR

comparison of pain relievers during curattage

Intervention Type DRUG

Dexketoprofen trometamol

25 mg oral Dexofen Atabay ilaç Turkey

Group Type ACTIVE_COMPARATOR

comparison of pain relievers

Intervention Type DRUG

Lidocaine spray

2 puff on cervical mucosa (Xylocain Pump 100 Mg 50 Ml Sprey Astra Zeneca)

Group Type ACTIVE_COMPARATOR

comparison of pain relievers during curattage

Intervention Type DRUG

pethidine

Aldolan 100 mg Liba Laboratuarı İstanbul Turkey

Group Type ACTIVE_COMPARATOR

comparison of pain relievers during curattage

Intervention Type DRUG

diclofenac sodium

Dicloron amp 75 mg Deva İlaç Levent İstanbul/Turkey

Group Type ACTIVE_COMPARATOR

comparison of pain relievers during curattage

Intervention Type DRUG

Interventions

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comparison of pain relievers during curattage

Intervention Type DRUG

comparison of pain relievers

Intervention Type DRUG

comparison of pain relievers during curattage

Intervention Type DRUG

comparison of pain relievers during curattage

Intervention Type DRUG

comparison of pain relievers during curattage

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* multiparous participants
* abnormal uterine bleeding
* postmenopausal bleeding
* myoma uteri causing menometrorrhagia
* cervical polyp
* tamoxifen treatment for breast cancer
* adnexial mass

Exclusion Criteria

* abortions
* pregnancy
* primiparity
* diabetes mellitus
* tendency to bleed such as thrombocytopenia
* factor deficiency
* functional disorders of platelets
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kayseri Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gökhan Açmaz

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kayseri Education and Research Hospital of Medicine

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 26609031 (View on PubMed)

Other Identifiers

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{kayseriERH}

Identifier Type: -

Identifier Source: org_study_id