Contraception
Conditions
Brief summary
the aim of the present study is to compare safety and efficacy of cervical Lidocaine-Prilocaine cream versus glyceryl trinitrate cream on pain perception during levonorgestrel- intrauterine device insertion among nulliparous women: a randomized double-blind controlled trial
Interventions
2 mL of the Lidocaine-Prilocaine cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion
2 mL of the glyceryl trinitrate cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion
DRUGplacebo cream
2 mL of the placebo cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion
Sponsors
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
* young and adolescent women requesting LNG-IUD insertion
Exclusion criteria
* parous women and contraindications to LNG-IUD placement or to the study drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain during LNG-IUD insertion | 5 minutes | pain during LNG-IUD insertion evaluated by 10 cm Visual analog scale where 0=no pain and 10=worst pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of the procedure | 10 minutes | duration of the procedure from speculum in to speculum out |
Contacts
Primary ContactAHMED SAMY
Outcome results
None listed