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
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