Glyceryl Trinitrate Versus Lidocaine Cream for IUD Insertion

IUD Insertion Clinical Trial

— GTN-IUD  

Official title:

Topical Glyceryl Trinitrate Versus Lidocaine Cream as Analgesia for IUD Insertion: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708251
• Other study ID #: GTN
• Status: Completed
• Phase: Phase 4
• First received: March 10, 2016
• Last updated: July 11, 2017
• Start date: October 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive method that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion criteria:

1. Women not taken analgesics or anxiolytics in the 24 hours prior insertion

2. Women not taken misoprostol prior to IUD insertion

3. No contraindication to or history of allergic reaction to lidocaine or NO donors.

4. Women who will accept to participate in the study

Exclusion criteria:

1. Lidocaine allergy

2. History of migraine or chronic headache

3. Any contraindication to IUD placement

Related Conditions & MeSH terms

• IUD Insertion

Intervention

Drug:
• glyceryl trinitrate cream

• lidocaine cream

• placebo cream

Locations

Country	Name	City	State
Egypt	Ahmed Abbas	Assiut	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean pain score during IUD insertion		3 minutes
Secondary	Patient satisfaction score after the procedure		3 minutes