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

Ain Shams University

Status and phase: Unknown; Phase 4

Conditions: Drug Usage

Treatments: Drug: Lidocaine; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01496105

ali elyan 2011

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

lidocaine spray 10%

Active Comparator group

Treatment:

Drug: Lidocaine

Saline

Placebo Comparator group

Treatment:

Drug: saline