Comparative Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in IUD Insertion
Phase 4
- Conditions
- Contraception
- Interventions
- Registration Number
- NCT04339361
- Lead Sponsor
- Cairo University
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 111
Inclusion Criteria
- nulliparous women requesting levonorgestrel IUD insertion
Exclusion Criteria
- multiparous women, allergy or contraindication to study drugs or contraindications to LNG-IUD insertion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lidocaine spray lidocaine spray four puffs (50ml, 10 mg/puff) of lidocaine spray will be applied to the cervical canal and cervix before tenaculum placement plus vaginal placebo will be given 3 hours before IUD insertion placebo placebo vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement vaginal dinoprostone vaginal dinoprostone vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement
- Primary Outcome Measures
Name Time Method pain during IUD insertion 2 minutes pain during IUD insertion assessed by 10 cm visual analog scale where 0 denotes no pain and 10 denotes the worst pain imaginable
- Secondary Outcome Measures
Name Time Method insertion duration 5 minutes duration of LNG-IUD insertion from speculum in to speculum out