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

Phase 4

• Conditions: Drug Usage
• Interventions: Drug: Lidocaine; Drug: saline

• Registration Number: NCT01496105
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Status Verified: 2011-12
• Primary Completion: 2011-12
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-20
• Last Update Submitted: 2011-12-20
• Study First Posted: 2011-12-21
• Last Update Posted: 2011-12-21
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine spray 10%	Lidocaine	-
Saline	saline	-

Primary Outcome Measures

Name	Time	Method
VAS score of Pain	5 minutes from lidocaine spraying ( after application of tenaculum)

Trial Locations

Locations (1)

Ain shams university hospital; 🇪🇬 Cairo, Egypt