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The purpose of this study is to evaluate pre-procedural anxiety and patient pain perception with IUD insertion/ EMB procedure when using analgesia versus no analgesia by the end of the study and to evaluate the effect of age, race, parity, type of IUD and anxiety on pain and to offer better pain management in our patient population, undergoing IUD insertion/EMB procedure at the end of our study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracervical block- Lidocaine without epinephrine with Hydroxyzine hydrochloride if needed | Experimental |
| |
| Benzocaine Gel applied to the cervix with Hydroxyzine hydrochloride if needed | Experimental |
| |
| No analgesia with Hydroxyzine hydrochloride if needed | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracervical block- Lidocaine without epinephrine | Drug | 1-2 cc of Lidocaine at the tenaculum site on the cervix at 12 o-clock will be injected after pain scale #1 is completed. Pain scale #2 will be done then 3 cc of 1% lidocaine at 4 and 8 o'clock position of the cervix will be administered. The IUD insertion or EMB will be performed nd pain scale #3 will be done. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain perception during IUD insertion as assessed by the Faces Pain Visual Analogue Scale (VAS) | VAS is scored from 1-10, higher score indicating greater pain | baseline (with the speculum in place before pain management procedures), after tenaculum placement (but before IUD placement or EMB) and immediately after IUD insertion or EMB. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety as assessed by the General Anxiety Disorder-7 (GAD-7) scale | baseline, and after taking Hydroxyzine about 15-30 mins before procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pamela Berens, MD | Contact | (713) 500-6471 | Pamela.D.Berens@uth.tmc.edu | |
| Sunbola A Ademola | Contact | (713) 500-6410 | Sunbola.S.Ashimi@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pamela Berens, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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|
| Benzocaine Gel applied to the cervix | Drug | After pain scale #1 is performed , topical benzocaine will be applied to the cervix with Procto swabs and this will be allowed to remain on cervix for 203 minutes. Then Betadine will be applied to the cervix and surrounding vaginal tissue followed by pain scale #2. IUD insertion or EMB will be done followed by pain scale #3. |
|
| Hydroxyzine Hydrochloride | Drug | Preprocedure, a GAD 7 scoring will be performed to determine level of anxiety. If > 10 indicating Moderate anxiety, participants will be offered pretreatment with Anxiolytic (Hydroxyzine 25mg) approximately 15-20 mins before procedure. If this is done at the preceding visit, participants will be sent home with a prescription for hydroxyzine to be taken 10-15 mins before the procedure when participants are brought back for procedure visit. |
|
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D006919 | Hydroxyzine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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