Diclofenac Plus Lidocaine Gel for Pain Relief During Intrauterine Device Insertion(IUD).

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Diclofenac plus lidocaine

• Registration Number: NCT02332057
• Lead Sponsor: Cairo University

Brief Summary

The aim of this study is to determine the effectiveness of a combination of diclofenac and lidocaine gel in reducing pain during IUD insertion.

Detailed Description

Various studies evaluating the use of local anesthetics or misoprostol prior to IUD insertion have mixed results.We think that the combination of diclofenac and lidocaine gel could be more successful in relieving pain during IUD insertion than single therapy.The aim of this study is to determine the effectiveness of a combination of diclofenac and lidocaine gel in reducing pain during IUD insertion.

Study Timeline

• Study First Submitted: 2015-01-04
• Study First Submitted QC: 2015-01-04
• Study First Posted: 2015-01-06
• Study Start: 2015-02
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Patients of reproductive age requesting IUD for contraception

Exclusion Criteria

• Patients with contraindications to IUD insertion ( less than 6 weeks postpartum, less than 2 weeks after abortion, uterine anomalies, fibroid distorting uterine cavity, pregnancy, pelvic inflammatory disease, cervicitis, uterine depth less than 6 cm or more than 9 cm) , previous IUD insertion, allergy to diclofenac or lidocaine, peptic ulcer , asthma, bleeding disorders, cardiac, liver or kidney diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablets is administered 1 hour before IUD insertion and placebo gel is placed on cervix three minutes before IUD insertion
Diclofenac plus lidocaine	Diclofenac plus lidocaine	Diclofenac(100 mg) is administered 1 hour before IUD insertion and lidocaine gel is placed on cervix three minutes before IUD insertion

Primary Outcome Measures

Name	Time	Method
Intensity of pain	Pain intensity will be assessed by visual analogue scale during the procedure [an expected average of 3 minutes]

Secondary Outcome Measures

Name	Time	Method
Adverse effects of diclofenac and lidocaine	Within 24 hours after IUD insertion

Trial Locations

Locations (1)

Obstetrics and Gynecology Department,Cairo university; 🇪🇬 Cairo, Egypt