Comparative Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in IUD Insertion

Cairo University111 enrolled

Overview

the aim of this study is to compare the safety and Efficacy of Lidocaine Spray Versus Vaginal dinoprostone in relieving pain during levonorgestrel IUD Insertion in nulliparous women

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

111

Conditions

Contraception

Interventions

lidocaine sprayDRUG

four puffs (50 ml, 10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion

vaginal dinoprostoneDRUG

vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

placeboDRUG

vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * nulliparous women requesting levonorgestrel IUD insertion Exclusion Criteria: * multiparous women, allergy or contraindication to study drugs or contraindications to LNG-IUD insertion

Outcomes

Primary Outcomes

pain during IUD insertion

pain during IUD insertion assessed by 10 cm visual analog scale where 0 denotes no pain and 10 denotes the worst pain imaginable

Time frame: 2 minutes

Secondary Outcomes

insertion duration

duration of LNG-IUD insertion from speculum in to speculum out

Time frame: 5 minutes

Central Contacts

AHMED SAMY

CONTACT

+201100681167 ahmedsamy8233@gmail.com

Data from ClinicalTrials.gov

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