Comparative 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
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Cairo University
- Enrollment
- 195
- Primary Endpoint
- pain during LNG-IUD insertion
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- Female
- Accepts 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.
Arms & Interventions
Lidocaine-Prilocaine cream
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
Intervention: Lidocaine-Prilocaine cream (Drug)
glyceryl trinitrate cream
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
Intervention: glyceryl trinitrate cream (Drug)
placebo 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
Intervention: placebo cream (Drug)
Outcomes
Primary Outcomes
pain during LNG-IUD insertion
Time Frame: 5 minutes
pain during LNG-IUD insertion evaluated by 10 cm Visual analog scale where 0=no pain and 10=worst pain imaginable
Secondary Outcomes
- duration of the procedure(10 minutes)
Investigators
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University