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

Information source: Cairo University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Diclofenac plus lidocaine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Cairo University

Official(s) and/or principal investigator(s):
Usama M Fouda, M.D,PhD, Study Chair, Affiliation: Cairo University

Overall contact:
Usama M Fouda, M.D,PhD, Phone: 01095401375, Ext: +2, Email: umfrfouda@yahoo.com

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.

Clinical Details

Official title: Diclofenac Plus Lidocaine Gel for Pain Relief During Intrauterine Device (IUD) Insertion. A Randomized Double Blinded Placebo-controlled Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Intensity of pain

Secondary outcome: Adverse effects of diclofenac and lidocaine

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.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Usama M Fouda, M.D,PhD, Phone: 01095401375, Ext: +2, Email: umfrfouda@yahoo.com

Obstetrics and Gynecology Department,Cairo university, Cairo, Egypt; Recruiting
Usama M. Fouda, M.D , PhD, Phone: 01095401375, Ext: +2, Email: umfrfouda@yahoo.com
Additional Information

Related publications:

McNicholas CP, Madden T, Zhao Q, Secura G, Allsworth JE, Peipert JF. Cervical lidocaine for IUD insertional pain: a randomized controlled trial. Am J Obstet Gynecol. 2012 Nov;207(5):384.e1-6. doi: 10.1016/j.ajog.2012.09.018. Epub 2012 Sep 20.

Starting date: February 2015
Last updated: February 28, 2015

Page last updated: August 23, 2015

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