Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in Reducing Pain During IUD Insertion in Adolescents and Nulliparous Women: a Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- lidocaine spray
- Conditions
- Contraception
- Sponsor
- Cairo University
- Enrollment
- 147
- Locations
- 1
- Primary Endpoint
- pain during IUD insertion
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
Investigators
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University
Eligibility Criteria
Inclusion Criteria
- •adolescent and young nulliparous women requesting IUD insertion
Exclusion Criteria
- •multiparous women, contraindications to IUD insertion or to study drugs
Arms & Interventions
lidocaine spray
four puffs (10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion
Intervention: lidocaine spray
vaginal misoprostol
vaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
Intervention: vaginal misoprostol
placebo
vaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
Intervention: placebo
Outcomes
Primary Outcomes
pain during IUD insertion
Time Frame: 5 minutes
pain during IUD insertion evaluated by visual analog scale where 0 denotes no pain and 10 cm denotes the worst pain imaginable
Secondary Outcomes
- duration of IUD insertion(5 minutes)