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Clinical Trials/NCT01496105
NCT01496105
Unknown
Phase 4

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

Ain Shams University1 site in 1 country200 target enrollmentJuly 2011
ConditionsDrug Usage
InterventionsLidocainesaline

Overview

Phase
Phase 4
Intervention
Lidocaine
Conditions
Drug Usage
Sponsor
Ain Shams University
Enrollment
200
Locations
1
Primary Endpoint
VAS score of Pain
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
January 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Saied Eldin Elsafty

Lecturer of Obstetrics and Gynecology

Ain Shams University

Eligibility Criteria

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

Arms & Interventions

lidocaine spray 10%

Intervention: Lidocaine

Saline

Intervention: saline

Outcomes

Primary Outcomes

VAS score of Pain

Time Frame: 5 minutes from lidocaine spraying ( after application of tenaculum)

Study Sites (1)

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