Different Analgesics Prior to Intrauterine Device (IUD) Insertion: Is There Any Evidence?

Study Overview
=================
Brief Summary
-----------------
Different ways of reducing pain during IUD insertion have been explored. So a randomized study will be conducted to test their role

Detailed Description
-----------------
A randomized clinical controlled trial of women undergoing IUD insertion. Participants in the study groups will be randomly assigned by labeled opaque envelopes to either1% lidocaine (Xylocaine 1%, Astra Zeneca, Egypt), misoprostol (Sigma, Egypt), naproxen (Naprosyn, Syntax, Egypt) or placebo tablets.

Official Title
-----------------
Different Analgesics Prior to IUD Insertion: Is There Any Evidence?

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

Intervention / Treatment
-----------------
* Drug: Lidocaine
* Drug: oral misoprostol
* Drug: naproxen
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are considered eligible if: they are alert oriented and co-operative to response to the visual analogue scale (VAS). They will sign the informed consent to participate in the clinical trial before entering the study. Willingness to be randomized and complete study questionnaires. Exclusion Criteria: Participants are excluded from participation if they are ineligible for an IUD by accepted criteria of our institution such as: A lidocaine allergy Copper allergy Current cervicitis Pelvic inflammatory disease (PID) within 3 months Uterine anomalies Pain medication within 6 hours before insertion Misoprostol administration within 24 hour before insertion History of cervical surgery and contraindication to study medications.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lidocaine group<br>Group A will receive 10 ml 1% lidocaine (Xylocaine 1%, Astra Zeneca, Egypt) Para cervical block prior to insertion of IUD (injection sites at cervix-vaginal junction typically at 4 ,8 O'clock), Then 3 minutes waiting period between the administration of the Para cervical block and IUD insertion, | Drug: Lidocaine<br>* intracervical injection<br>|
| Active Comparator: misoprostol group<br>Group B will receive 400 mcg oral misoprostol (Sigma, Egypt) prior to IUD insertion | Drug: oral misoprostol<br>* oral treatment<br>|
| Active Comparator: non steroid group<br>Group C will receive oral naproxen (Naprosyn, Syntax, Egypt) prior to IUD insertion | Drug: naproxen<br>* oral treatment<br>|
| Placebo Comparator: placebo group<br>group D will receive placebo tablets. | Other: placebo<br>* oral treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| current pain level with IUD insertion and 15 minutes post procedure measured by the Visual Analogue Scale. | A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range to across a continuum of values and can not easily to be directly measured. Subjects pain using a 10 point visual analogue scale (-+VAS, anchors: 0=non, 10 = worst imaginable). The participants were asked to mark their pre IUD insertion pain expectancies initially, then to mark their pain during different steps of IUD placement. | 15 minutes |