Contraception
Conditions
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
Interventions
DRUGlidocaine spray
four puffs (10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion
DRUGvaginal misoprostol
vaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
DRUGplacebo
vaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
Sponsors
Algazeerah hospital
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* adolescent and young nulliparous women requesting IUD insertion
Exclusion criteria
* multiparous women, contraindications to IUD insertion or to study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| duration of IUD insertion | 5 minutes | duration of IUD insertion from speculum in to speculum out |
Countries
Egypt
Outcome results
None listed