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

Not Applicable

Completed

• Conditions: Pain and Curettage
• Interventions: Drug: comparison of pain relievers during curattage; Drug: comparison of pain relievers

• Registration Number: NCT01993589
• Lead Sponsor: Kayseri Education and Research Hospital

Brief 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 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 Timeline

• Study Start: 2012-11
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2013-11-09
• Study First Submitted QC: 2013-11-20
• Last Update Submitted: 2013-11-20
• Study First Posted: 2013-11-25
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain reliever	comparison of pain relievers during curattage	1000 mg paracetamol (Parol 1 g Atabay ilaç Turkey)
Dexketoprofen trometamol	comparison of pain relievers	25 mg oral Dexofen Atabay ilaç Turkey
Lidocaine spray	comparison of pain relievers during curattage	2 puff on cervical mucosa (Xylocain Pump 100 Mg 50 Ml Sprey Astra Zeneca)
pethidine	comparison of pain relievers during curattage	Aldolan 100 mg Liba Laboratuarı İstanbul Turkey
diclofenac sodium	comparison of pain relievers during curattage	Dicloron amp 75 mg Deva İlaç Levent İstanbul/Turkey

Primary Outcome Measures

Name	Time	Method
Pain	1 year

Trial Locations

Locations (1)

Kayseri Education and Research Hospital of Medicine; 🇹🇷 Kayseri, Turkey