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NCT01496105 Clinical Trial

Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion

Drug Usage Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01496105
Other study ID # ali elyan 2011
Secondary ID
Status Recruiting
Phase Phase 4
First received December 13, 2011
Last updated December 20, 2011
Start date July 2011
Est. completion date January 2012

Study information
Verified date December 2011
Source Ain Shams University
Contact Mohamed S.Eldin Elsafty, Lecturer
Phone +201003922211
Email emeira2@gmail.com
Is FDA regulated No
Health authority Egypt: Ministry of Health and Population
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the topical use of lidocaine spray 10% on the cervix is an effective way to reduce pain during IUCD insertion.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date January 2012
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Age 18-45

- Speak Arabic or English

Exclusion Criteria:

- History of cervical surgery

- Known hypersensitivity to topical analgesics

- First trimester abortion or miscarriage in the previous six weeks

- Second trimester abortion or miscarriage in the previous 12 weeks

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Lidocaine

• saline

Locations
Country Name City State
Egypt Ain shams university hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary VAS score of Pain 5 minutes from lidocaine spraying ( after application of tenaculum) No
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