Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in IUD Insertion

Cairo University147 enrolled

Overview

the aim of the present study is to compare the safety and efficacy of lidocaine spray versus misoprostol in reducing pain during IUD insertion in adolescents and nulliparous women

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

147

Conditions

Contraception

Interventions

lidocaine sprayDRUG

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

vaginal misoprostolDRUG

vaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

placeboDRUG

vaginal placebo 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: * adolescent and young nulliparous women requesting IUD insertion Exclusion Criteria: * multiparous women, contraindications to IUD insertion or to study drugs

Locations (1)

Ahmed Ashour

Giza, Egypt

Outcomes

Primary Outcomes

pain during IUD insertion

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

Time frame: 5 minutes

Secondary Outcomes

duration of IUD insertion

duration of IUD insertion from speculum in to speculum out

Time frame: 5 minutes

Data from ClinicalTrials.gov

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