Cervical Lidocaine-Prilocaine Cream vs Glyceryl Trinitrate Cream in Nulliparous Women With LNG-IUD Insertion

Phase 4

• Conditions: Contraception
• Interventions: Drug: placebo cream; Drug: Lidocaine-Prilocaine cream; Drug: glyceryl trinitrate cream

• Registration Number: NCT04355598
• Lead Sponsor: Cairo University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-18
• Study First Submitted QC: 2020-04-18
• Last Update Submitted: 2020-04-18
• Study First Posted: 2020-04-21
• Last Update Posted: 2020-04-21
• Study Start: 2020-04-30
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 195

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo cream	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
Lidocaine-Prilocaine cream	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
glyceryl trinitrate cream	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
duration of the procedure	10 minutes	duration of the procedure from speculum in to speculum out