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| Name | Class |
|---|---|
| Menoufia University | OTHER |
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Different ways of reducing pain during IUD insertion have been explored. So a randomized study will be conducted to test their role
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocaine group | Active Comparator | 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, |
|
| misoprostol group | Active Comparator | Group B will receive 400 mcg oral misoprostol (Sigma, Egypt) prior to IUD insertion |
|
| non steroid group | Active Comparator | Group C will receive oral naproxen (Naprosyn, Syntax, Egypt) prior to IUD insertion |
|
| placebo group | Placebo Comparator | group D will receive placebo tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | intracervical injection |
| |
| oral misoprostol |
| 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 |
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Inclusion Criteria:
Patients are considered eligible if:
Exclusion Criteria:
Participants are excluded from participation if they are ineligible for an IUD by accepted criteria of our institution such as:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menoufia University | Recruiting | Shebin Elkom | Egypt |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D016595 | Misoprostol |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Drug |
oral treatment |
|
| naproxen | Drug | oral treatment |
|
| placebo | Other | oral treatment |
|
| Alhayah national hospital | Recruiting | Abhā | Saudi Arabia |
|
| Aniline Compounds |
| D000588 | Amines |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |