Glyceryl Trinitrate Versus Lidocaine Cream for IUD Insertion

Study Overview
=================
Brief 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.

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

Conditions
-----------------
IUD Insertion

Intervention / Treatment
-----------------
* Drug: glyceryl trinitrate cream
* Drug: lidocaine cream
* Drug: placebo cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Women not taken analgesics or anxiolytics in the 24 hours prior insertion Women not taken misoprostol prior to IUD insertion No contraindication to or history of allergic reaction to lidocaine or NO donors. Women who will accept to participate in the study Exclusion criteria: Lidocaine allergy History of migraine or chronic headache Any contraindication to IUD placement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glyceryl trinitrate cream<br>The clinician will perform a bimanual examination, place the speculum, and cleanse the cervix with Betadine. 1 mL glyceryl trinitrate cream will be placed on the cervix at the anterior lip and 1 mL in the cervix up to the level of the internal os using cotton swab. | Drug: glyceryl trinitrate cream<br> <br> |
| Experimental: lidocaine cream<br>The clinician will perform a bimanual examination, place the speculum, and cleanse the cervix with Betadine. 1 mL lidocaine creamwill be placed on the cervix at the anterior lip and 1 mL in the cervix up to the level of the internal os using cotton swab. | Drug: lidocaine cream<br> <br> |
| Placebo Comparator: placebo cream<br>The clinician will perform a bimanual examination, place the speculum, and cleanse the cervix with Betadine.1 mL placebo cream will be placed on the cervix at the anterior lip and 1 mL in the cervix up to the level of the internal os using cotton swab. | Drug: placebo cream<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain score during IUD insertion |  | 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction score after the procedure |  | 3 minutes |