Comparative Safety and Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in Relieving Pain During Levonorgestrel IUD Insertion
Overview
- Phase
- Phase 4
- Intervention
- lidocaine spray
- Conditions
- Contraception
- Sponsor
- Cairo University
- Enrollment
- 111
- Primary Endpoint
- pain during IUD insertion
- Last Updated
- 6 years ago
Overview
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
Investigators
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University
Eligibility Criteria
Inclusion Criteria
- •nulliparous women requesting levonorgestrel IUD insertion
Exclusion Criteria
- •multiparous women, allergy or contraindication to study drugs or contraindications to LNG-IUD insertion
Arms & Interventions
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
Intervention: lidocaine spray
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
Intervention: vaginal dinoprostone
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
Intervention: placebo
Outcomes
Primary Outcomes
pain during IUD insertion
Time Frame: 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 Outcomes
- insertion duration(5 minutes)