Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in IUD Insertion
Phase 3
Completed
- Conditions
- Contraception
- Interventions
- Registration Number
- NCT04339049
- Lead Sponsor
- Cairo University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 147
Inclusion Criteria
- adolescent and young nulliparous women requesting IUD insertion
Exclusion Criteria
- multiparous women, contraindications to IUD insertion or to study drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lidocaine spray lidocaine spray four puffs (10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion vaginal misoprostol vaginal misoprostol vaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement placebo placebo vaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
- Primary Outcome Measures
Name Time Method pain during IUD insertion 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 Outcome Measures
Name Time Method duration of IUD insertion 5 minutes duration of IUD insertion from speculum in to speculum out
Trial Locations
- Locations (1)
Ahmed Ashour
🇪🇬Giza, Egypt